FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 5325314
·
Received December 23, 2015
Report
- Report Number
- 2032227-2015-78033
- Event Type
- Injury
- Date Received
- December 23, 2015
- Date of Event
- December 6, 2015
- Report Date
- December 9, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO DAMAGE TO THE RESERVOIR COMPARTMENT NOTED. UNIT RECEIVED WITH PARTIALLY BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT RESERVOIR TUBE WINDOW CORNER AND MISSING RESERVOIR TUBE O-RING. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED VIA PHONE CALL TO HAVE WOKEN UP WITH BLOOD GLUCOSE OF 561 MG/DL. CUSTOMER REPORTED THAT IT WAS NOTICED THAT THE RESERVOIR COMPARTMENT WAS DAMAGED AND RESERVOIR WOULD NOT STAY IN AND HE O-RING CAME OUT. CUSTOMER'S BLOOD GLUCOSE WAS 252 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848423 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |