FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2072799
·
Received March 31, 2011
Report
- Report Number
- 3004209178-2011-80898
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 CUSTOMER HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HIS LAST INFUSION SET CHANGE WAS THE MORNING OF THE EVENT AND HE USED A MODEL MMT-396 QUICK-SET INFUSION SET. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME BUT FAILED THE HIGH PRESSURE TEST TWICE AND WAS STUCK IN A REWIND LOOP. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | MODEL MMT-396, LOT 9200573.| UNOMEDICAL QUICK-SET INSULIN INFUSION SET: |