FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAH PRDGM INS PK
MDR report key: 1911893
·
Received November 24, 2010
Report
- Report Number
- 3004209178-2010-83435
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- November 13, 2010
- Report Date
- November 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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. 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
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. TWO DAYS LATER THE MOTHER CALLED BACK AND STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE MOTHER STATED THAT SHE CALLED HER DAUGHTER'S NURSE, WHO SUGGESTED A REPLACEMENT OF THE INSULIN PUMP. ADVISED THE MOTHER TO PLACE THE CUSTOMER ON A BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAH PRDGM INS PK | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |