FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4133538
·
Received October 1, 2014
Report
- Report Number
- 2032227-2014-31118
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- August 31, 2014
- Report Date
- September 1, 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
THE INSULIN PUMP HAD A CONSTANT MOTOR ERROR ALARM DURING THE REWIND DUE TO A MOTOR ENCODER SIGNAL OUT OF PHASE. THE DISPLACEMENT TEST COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARM. THE INSULIN PUMP HAD CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.
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
CUSTOMER REPORTED A MOTOR ERROR ALARM DURING PRIMING. THE BLOOD GLUCOSE READING IS 218 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613299 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-522RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |