FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3974292 · Received August 1, 2014

Report

Report Number: 3004209178-2014-89139
Event Type: Malfunction
Date Received: August 1, 2014
Date of Event: July 2, 2014
Report Date: July 2, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA
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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE

Additional Manufacturer Narrative · 1

THE INSULIN PUMP BUTTONS FUNCTIONED PROPERLY DURING THE TESTING. NO KEYPAD CONNECTOR WAS UNLOCKED. NO CORROSION OR WATER DAMAGE WAS NOTED ON THE KEYPAD TRACES. THE INSULIN PUMP HAD A CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

Description of Event or Problem · 1

IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP'S DOWN ARROW BUTTON WAS NOT RESPONSIVE. CUSTOMER STATED THEY REMOVED AND REINSERTED THE BATTERIES, HOWEVER THE ISSUE RETURNED. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 196 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
449992	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	21 YR