FDA Adverse Event
Injury
Summary report: N
PUMP MMT-512LNAP PRDGM INS PL EN US LN
MDR report key: 1033881
·
Received April 24, 2008
Report
- Report Number
- 2032227-2008-00708
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- April 11, 2008
- Report Date
- April 12, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K030531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH NAUSEA, VOMITING AND DEHYDRATION. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER ALSO STATED THAT SHE HAD A KIDNEY AND VAGINAL INFECTION, WHICH SHE WAS TAKING ANTI-BIOTICS FOR. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-512LNAP PRDGM INS PL EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-512LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |