FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3993966
·
Received August 8, 2014
Report
- Report Number
- 2032227-2014-06749
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- September 4, 2012
- Report Date
- July 11, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. THE DEVICE WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, AND MISSING END CAP STICKER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 237 MG/DL. CUSTOMER DID NOT HOLD THE BUTTON FOR THREE MINUTES OR LONGER. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468930 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-522LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |