FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-508GB EA INSULIN BL DE
MDR report key: 1070383
·
Received June 30, 2008
Report
- Report Number
- 2032227-2008-01091
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 10, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K990801
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP FAILED THE HIGH-PRESSURE TEST. NO BLOOD GLUCOSE READING WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-508GB EA INSULIN BL DE | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-508GB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |