FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4111131
·
Received September 23, 2014
Report
- Report Number
- 2032227-2014-23013
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. CRACKED END CAP ALSO NOTED. (B)(4).
Description of Event or Problem · 1
CUSTOMER CALLED TO REPORT THE INSULIN PUMP HAD A CRACK AFTER IT WAS BUMPED DURING THE PRIMING PROCESS. BLOOD GLUCOSE READING WAS 116 MG/DL. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591723 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |