FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
MDR report key: 7165201
·
Received January 4, 2018
Report
- Report Number
- 3004209178-2018-40836
- Event Type
- Injury
- Date Received
- January 4, 2018
- Date of Event
- December 24, 2017
- Report Date
- January 4, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 00643169513914
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN 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 VIA PHONE CALL THAT THEY WERE HOSPITALIZED ON (B)(6) 2017 DUE TO HIGH BLOOD GLUCOSE VALUE OF 400, 497 AND 410 MG/DL. PATIENT'S OTHER BLOOD GLUCOSE VALUE: 102, 160, 495, 300 TO 524. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS AND PUMP. CUSTOMER ALLEGED THE PUMP FOR UNDER DELIVERING INSULIN. CUSTOMER DECLINED TO TROUBLESHOOT FOR THEIR BLOOD GLUCOSE LEVELS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6941 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAS | A5723LNASJ | 00643169513914 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization |