FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 2970617 · Received February 20, 2013

Report

Report Number: 3004209178-2013-91204
Event Type: Malfunction
Date Received: February 20, 2013
Date of Event: February 6, 2013
Report Date: February 6, 2013
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM.

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.

Description of Event or Problem · 1

THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 130MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR AND LOW BATTERY ALARMS. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND THE TEST FAILED TWICE. THE CALLER ALSO STATED THAT THE INSULIN SQUIRTED OUT WHILE PRIMING THE DEVICE. THE DISPLACEMENT TEST WAS PERFORMED AND PASSED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. N FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
74659	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-522NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR