FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4860571 · Received June 22, 2015

Report

Report Number: 3004209178-2015-67624
Event Type: Malfunction
Date Received: June 22, 2015
Date of Event: June 3, 2015
Report Date: June 3, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Additional Manufacturer Narrative · 1

THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. THE INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP HAD CRACKED CASE AT DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT AT BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

Description of Event or Problem · 1

IT WAS REPORTED VIA PHONE CALL, THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM. IT WAS ALSO MENTIONED THAT THE INSULIN PUMP WAS EXPOSED TO AN MRI. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME WAS UNKNOWN. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
403501	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR