FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 2863302 · Received December 10, 2012

Report

Report Number: 3004209178-2012-91182
Event Type: Malfunction
Date Received: December 10, 2012
Date of Event: November 24, 2012
Report Date: November 24, 2012
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
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

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TEST. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK IN MOTOR ERROR LOOP DURING BOLUS AND BASAL DELIVERY. ERROR ALARM CONFIRMED IN HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 142MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE CALLER WITH PERFORMING THE DISPLACEMENT TEST, AND THE TEST FAILED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACKUP. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	OYC	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAB

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR