FDA Adverse Event
Injury
Summary report: N
PUMP MMT-511NAL PRDGM EA INS CL EN
MDR report key: 1192426
·
Received October 7, 2008
Report
- Report Number
- 2032227-2008-01745
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K001829
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT SHE HAD MULTIPLE LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE LEVEL WAS PROVIDED AT THE TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED, AND THE BASAL RATES AND SETTINGS IN THE INSULIN PUMP WERE CORRECT. CUSTOMER STATED THAT THE AMOUNT OF INSULIN IN RESERVOIR MATCHES WITH THE AMOUNT ON THE SCREEN. PERFORMED THE DISPLACEMENT TEST AND THE INSULIN PUMP FAILED. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-511NAL PRDGM EA INS CL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-511NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |