FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4033276 · Received August 25, 2014

Report

Report Number: 3004209178-2014-97037
Event Type: Malfunction
Date Received: August 25, 2014
Date of Event: July 25, 2014
Report Date: July 25, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP, MINOR SCRATCHED AND CRACKED DISPLAY WINDOW.

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.

Description of Event or Problem · 1

IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE ALARM CANNOT BE CLEARED. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
512707	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-754WWL

Patients

Seq	Age	Sex	Outcome	Treatment
1