FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
MDR report key: 1931129
·
Received December 8, 2010
Report
- Report Number
- 3004209178-2010-83551
- Event Type
- Injury
- Date Received
- December 8, 2010
- Date of Event
- May 13, 2009
- Report Date
- November 19, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED BECAUSE, THE INSULIN PUMP WAS MALFUNCTIONING. IT WAS STATED THAT THE CUSTOMER WAS INVOLVED IN A CAR ACCIDENT MORE THAN A YEAR AGO. THE REPORTER STATED THAT THE CUSTOMER RECEIVED A REPLACEMENT PUMP AFTER THE ACCIDENT. THE REPORTER STATED THAT THE DEVICE WAS MALFUNCTIONING AND THE CUSTOMER ENDED IN THE HOSPITAL FOR UNEXPLAINED HIGH BLOOD GLUCOSE. 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 | Hospitalization |