FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722LNAP PRDGM INS PL EN ML
MDR report key: 1853280
·
Received September 29, 2010
Report
- Report Number
- 2032227-2010-82782
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED MULTIPLE FAILED BATTERY TEST ALARMS. TROUBLESHOOTING WAS PERFORMED, BUT THE ALARMS CONTINUED. THE CUSTOMER LATER CALLED TO REPORT THAT HER BLOOD GLUCOSE LEVELS WERE UP TO 500 MG/DL, AND ENDED UP GOING TO THE EMERGENCY ROOM. THE INSULIN PUMP WAS REPLACED DUE TO THE ALARMS. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722LNAP PRDGM INS PL EN ML | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization |