FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL
MDR report key: 7779885
·
Received August 14, 2018
Report
- Report Number
- 2032227-2018-12796
- Event Type
- Malfunction
- Date Received
- August 14, 2018
- Date of Event
- January 26, 2012
- Report Date
- August 13, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 00613994402110
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNIT RECEIVED WITH STRIPPED COIN SLOT ON BATTERY CAP(P). NO UNEXPECTED FAILED BATTERY TEST ALARM NOTED. ALL OPERATING CURRENTS WERE IN SPEC. MP 02-09-2012.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA PHONE CALL THAT THEY GOT BATTERY FAILED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 252MG/DL. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL BE RETURNED FOR THE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623254 | PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAL | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-522NAL | A5522NALJ | 00613994402110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |