FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
MDR report key: 1873974
·
Received October 15, 2010
Report
- Report Number
- 3004209178-2010-83118
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 1, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP DELIVERS LESS INSULIN THAN WHAT IT WAS PROGRAMMED. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE DEVICE ALARMED NO DELIVERY BEFORE COMPLETING A BOLUS. THE MOTHER ALSO STATED THAT THE INSULIN PUMP UNDER DELIVERED BY 5.0 UNITS. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAP PRDGM INS V2.2 PL EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |