FDA Adverse Event
Death
Summary report: N
H-TRONPULS V100 INSULIN INFUSION PUMP
MDR report key: 283332
·
Received June 28, 2000
Report
- Report Number
- 9614448-2000-00001
- Event Type
- Death
- Date Received
- June 28, 2000
- Date of Event
- May 13, 2000
- Report Date
- May 17, 2000
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS AG
- Product Code
- LZG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT FOUND DEAD AT HOME ON MORNING OF 5/13/00. RESUSCITATION BY MEDICAL PERSONNEL UNSUCCESSFUL. CORONER'S INVESTIGATION IDENTIFIED HYPOGLYCEMIA AS CAUSE OF DEATH. PUMP RETURNED FOR EVALUATION.
Description of Event or Problem · 1
SUPPLEMENTAL INFO: CAUSE OF DEATH UNKNOWN ACCORDING TO THE CRIMINAL INVESTIGATION DEPT. INDICATION FOR HYPERGLYCEMIA ACCORDING TO DETAILED FORENSIC EXPERTISE. THE DEVICE WAS NOT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | H-TRONPULS V100 INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS AG | H-TRONPLUS V100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Death | NA.| INSULIN, INSULIN INFUSION SET, DATES OF TREATMENT- |