FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
MDR report key: 1902543
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-83311
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 THE INSULIN PUMP DID NOT ALARM NO DELIVERY WHEN THE CANNULAS WERE BENT, AND HIS BLOOD GLUCOSE WAS HIGH. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 155MG/DL. THE CUSTOMER STATED THAT WHEN HE INSERTED ANOTHER INFUSION SET, HIS BLOOD GLUCOSE RETURNED TO NORMAL, THEN LATER HIS GLUCOSE LEVEL STARTED GOING UP AGAIN. TROUBLESHOOTING WAS PERFORMED. RAN A PRIME TEST AND THE INSULIN EXITED. 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 | 31 YR |