FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2241468
·
Received August 9, 2011
Report
- Report Number
- 2032227-2011-02001
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 27, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP FAILED THE DISPLACEMENT TEST DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. THE INSULIN PUMP WAS MONITORED, AND NO UNEXPECTED VIBRATION WAS NOTED.
Description of Event or Problem · 1
THE CUSTOMER'S HUSBAND CALLED TO REPORT LOW BLOOD GLUCOSE LEVELS FOR THE PAST DAY. THE CUSTOMER'S MOST RECENT LOW BLOOD GLUCOSE READING WAS 26 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ACCURATE. THE CALLER STATED THAT SHE WORE THE INSULIN PUMP, DURING A CT SCAN A MONTH AGO, AND THE INSULIN PUMP HAS BEEN ACTING UP EVER SINCE. THE CALLER STATED THAT THE INSULIN PUMP VIBRATES FOR NO REASON, AND DISPLAYS NO ALARMS. THE HUSBAND REQUESTED A REPLACEMENT INSULIN PUMP. 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 MINIMED | MMT-522LNAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |