FDA Adverse Event
Malfunction
Summary report: N
MINIMED INFUSION PUMP
MDR report key: 153536
·
Received February 27, 1998
Report
- Report Number
- 2025512-1998-00018
- Event Type
- Malfunction
- Date Received
- February 27, 1998
- Date of Event
- January 10, 1998
- Report Date
- January 11, 1998
- Manufacturer
- MINIMED INC.
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
PT HOSPITALIZED DKA. MOTHER ATTRIBUTED DKA TO BAD EATING HABITS. PT WAS HAVING DIFFICULTY MAINTAINING BLOOD GLUCOSES FOR A WEEK PRIOR TO HOSPITALIZATION BUT WAS NOT MENTIONED TO MOTHER UNTIL INCIDENT. BLOOD GLUCOSES HAVE BEEN STABILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIMED INFUSION PUMP | INFUSION PUMP | LZG | MINIMED INC. | MMT-507UC | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Hospitalization |