FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4260262 · Received November 18, 2014

Report

Report Number: 2032227-2014-53903
Event Type: Malfunction
Date Received: November 18, 2014
Date of Event: October 14, 2014
Report Date: October 21, 2014
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

NO UNEXPECTED BUTTON ERROR ALARMS WERE NOTED. UNABLE TO PERFORM DISPLACEMENT, OPERATING CURRENTS, OFF NO POWER, PRIME OR EXCESSIVE NO DELIVERY TESTS DUE TO UNRESPONSIVE KEYPAD. THE PUMP HAD NO BUTTON RESPONSE ON THE ACT BUTTON DUE TO CORRODED KEYPAD TRACES. THE PUMP ALSO HAD A CRACKED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS AND STAINED END CAP STICKER.

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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER RECEIVED BUTTON ERROR AND NO DELIVERY ALARMS. THE CUSTOMER'S INSULIN PUMP ALSO HAD KEYPAD ISSUES. HER BLOOD GLUCOSE LEVEL WAS 180 MG/DL. SHE WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THE PRODUCT WAS RETURNED. NOTHING FURTHER TO REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
745868	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	26 YR