PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

Report

Report Number: 3004209178-2013-90235
Event Type: Injury
Date Received: January 11, 2013
Date of Event: December 27, 2012
Report Date: December 27, 2012
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
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 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.

Additional Manufacturer Narrative · 1

A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND BROKEN BATTERY TUBE THREADS.

Description of Event or Problem · 1

THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 320MG/DL. THE CUSTOMER EXPERIENCED DEHYDRATION, WEAK, COLD AND EXHAUSTED. THE CUSTOMER MENTIONED THAT SHE HAD TO CHANGE THE BATTERY EVERY OTHER DAY. TROUBLESHOOTING WAS PERFORMED AND THE ALARM HISTORY REVEALED LOW RESERVOIR ALARMS. THE CUSTOMER IS USING DURACELL BATTERIES. RECOMMENDED TO USE THE CORRECT BATTERY. FURTHER TESTING COULD NOT BE PERFORMED AS CUSTOMER REQUESTED THE DEVICE BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18534	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR