FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4871550 · Received June 26, 2015

Report

Report Number: 3004209178-2015-69079
Event Type: Malfunction
Date Received: June 26, 2015
Date of Event: June 8, 2015
Report Date: June 8, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

Additional Manufacturer Narrative · 1

THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE AND ALARMED FOR A BUTTON ERROR DUE TO CORRODED KEYPAD TRACES. 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 CRACKED BATTERY TUBE THREADS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414664	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-754WWS

Patients

Seq	Age	Sex	Outcome	Treatment
1