FDA Adverse Event
Death
Summary report: N
ACCU-CHEK D-TRON PLUS
MDR report key: 1033267
·
Received April 23, 2008
Report
- Report Number
- 2183996-2008-00580
- Event Type
- Death
- Date Received
- April 23, 2008
- Date of Event
- March 28, 2008
- Report Date
- April 21, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- N
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON 04/21/2008, IT WAS REPORTED THAT THE PT DIED ONE MONTH EARLIER. THE PRECISE CAUSE OF DEATH WAS NOT INDICATED IN THE REPORT. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK D-TRON PLUS | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | INSULIN| INSULIN INFUSION SET |