FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522RNAS PRDGM INS SK EN RC
MDR report key: 1812007
·
Received August 17, 2010
Report
- Report Number
- 2032227-2010-82376
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- July 23, 2010
- Report Date
- July 24, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER'S DAUGHTER CALLED FOR ASSISTANCE WITH THE FIXED PRIME. THE DAUGHTER THEN STATED THAT THE PARAMEDICS WERE CALLED LAST NIGHT BECAUSE THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS, THEN PASSED OUT. FOUND THAT THE CUSTOMER MAY HAVE OVER ESTIMATED FOR HIS CARBOHYDRATES. ALSO, THE TIME WAS OFF BY AN HOUR. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522RNAS PRDGM INS SK EN RC | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-522RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |