FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722RNAS PRDGM INS SK EN RC
MDR report key: 1864408
·
Received October 4, 2010
Report
- Report Number
- 2032227-2010-82858
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- September 17, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MEDTRONIC MINIMED
- 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 BLOOD GLUCOSE LEVELS ABOVE 500 MG/DL. THE CUSTOMER STATED THAT THE CANNULA WAS BENT AND HE DID NOT GET A NO DELIVERY ALARM. ADVISED THE CUSTOMER THAT WE WOULD LIKE TO CONDUCT THE HIGH PRESSURE TEST, BUT THE CUSTOMER DECLINED. MAILED THE TUBING TO THE CUSTOMER, AND ADVISED HIM TO CALL BACK TO CONDUCT THE TEST ONCE HE IS READY. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722RNAS PRDGM INS SK EN RC | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |