FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3945110 · Received July 18, 2014

Report

Report Number: 2032227-2014-04573
Event Type: Malfunction
Date Received: July 18, 2014
Date of Event: June 18, 2014
Report Date: June 18, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

ALL BUTTONS FUNCTIONED PROPERLY. NO MOISTURE DAMAGE ON KEYPAD TRACES OR NUMBERS SCROLLING UP NOTED. KEYPAD CONNECTOR WAS INSPECTED AND IT WAS LOCKED COMPLETELY. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF/NO POWER OR LOW BATTERY ALARM NOTED. NO BATTERY DEPLETION NOTED.

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

CUSTOMER REPORTED THE INSULIN PUMP KEPT BEEPING AND WAS STUCK FOR 12 HOURS. THE DEVICE SHOWS THE BATTERY IS COMPLETELY DEPLETED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 195 MG/DL. CUSTOMER STATED THE BUTTONS ON THE DEVICE ARE NOT WORKING. CUSTOMER STATED THE DEVICE HAS NOT BEEN EXPOSED TO ANY MOISTURE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421244	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-523LNAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR