FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4233433 · Received November 6, 2014

Report

Report Number: 2032227-2014-48528
Event Type: Malfunction
Date Received: November 6, 2014
Date of Event: October 7, 2014
Report Date: October 8, 2014
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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4)

Additional Manufacturer Narrative · 1

THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO DISPLAY ANOMALY WAS NOTED. NO BOLUS ANOMALY COULD BE VERIFIED AND THE FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE UNRESPONSIVE BUTTONS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, A MISSING END CAP STICKER, A CRACKED DISPLAY WINDOW AND A CRACKED CASE AT THE RESERVIOR TUBE WINDOW CORNER.

Description of Event or Problem · 1

IT WAS REPORTED BY THE CUSTOMER'S MOTHER, THAT THE NUMBERS ON THE INSULIN PUMP SCROLL UP WITH OUT ANY INPUT FROM THE CUSTOMER. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 354MG/DL. TROUBLESHOOTING OCCURRED. ADVISED INSULIN PUMP WOULD BE REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
714037	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAH

Patients

Seq	Age	Sex	Outcome	Treatment
1