FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715LNAL PRDGM INS V2.1 CL EN
MDR report key: 1812002
·
Received August 17, 2010
Report
- Report Number
- 2032227-2010-82367
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- July 23, 2010
- Report Date
- July 23, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED BY A NURSE, THAT THE CUSTOMER WAS IN A CAR ACCIDENT. THE NURSE STATED THAT THE ACCIDENT WAS NOT DIABETES RELATED, BUT THE INSULIN PUMP WAS DESTROYED IN THE ACCIDENT. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715LNAL PRDGM INS V2.1 CL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-715LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization |