FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 2863268 · Received December 10, 2012

Report

Report Number: 3004209178-2012-91149
Event Type: Injury
Date Received: December 10, 2012
Date of Event: November 23, 2012
Report Date: November 23, 2012
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY TESTS. NO MOTOR ERROR ALARMS NOTED.

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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED HAVING UNEXPLAINED HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS DELIVERY. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CALLER TO RUN THE DISPLACEMENT TEST AND PASSED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. DURING THE CALL, THE CUSTOMER MENTIONED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CALLER STATED THAT THIS BLOOD GLUCOSE IS STABLE AT THE TIME AND HAS LOWER DOWN. 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-723NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR		Hospitalization