Disetronic Medical Systems, Inc.
FDA adverse event reports naming Disetronic Medical Systems, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: DISETRONIC MEDICAL SYSTEMS, INC..
- Total reports
- 5,841
- Deaths
- 29
- Injuries
- 2,886
- Malfunctions
- 2,882
Reports per year
Source: FDA adverse event reports by year received, 1999–2013. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pump, Infusion, InsulinLZG4,543
- Set, Administration, IntravascularFPA1,197
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ58
- Pump, InfusionFRN18
- Hexokinase, GlucoseCFR6
- System, Test, Blood Glucose, Over The CounterNBW6
- Product code ------3
- Warmer, Thermal, Infusion FluidLGZ3
- Syringe, PistonFMF2
- Warmer, Infant RadiantFMT1
Recent recalls
- 2009-05-26TerminatedDevice Design
Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
- 2006-09-12TerminatedOther
Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
The battery may turn the pump off without warning due to a design change in the battery.
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and Ref. No 04626524001 (Distributed outside of the the U.S. only).
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- 2006-07-08TerminatedOther
Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
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