FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
MDR report key: 1942753
·
Received December 20, 2010
Report
- Report Number
- 3004209178-2010-83649
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 7, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HE DOES NOT BELIEVE HIS INSULIN IS BEING DELIVERED. THE CUSTOMER PERFORMED A PRIME TEST AND THE INSULIN EXITED. THE CUSTOMER REQUESTED TO TROUBLESHOOT THE DEVICE TO ENSURE IT ALARMS NO DELIVERY. SENDING A CLAMP TO THE CUSTOMER SO, WE CAN CONDUCT THE HIGH PRESSURE TEST. THE CUSTOMER STATED THE DEVICE ALARMED NO DELIVERY BEFORE, BUT IT HAS NOT WHEN HIS BLOOD GLUCOSE WAS RUNNING HIGH. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |