FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4811346 · Received June 2, 2015

Report

Report Number: 3004209178-2015-61551
Event Type: Malfunction
Date Received: June 2, 2015
Date of Event: May 12, 2015
Report Date: May 12, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 DUE TO MOISTURE DAMAGE TO THE KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A MISSING END CAP STICKER, A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNERS AND CRACKED BATTERY TUBE THREADS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT THE ALARM COULD NOT BE DELETED. CUSTOMER'S BLOOD GLUCOSE WAS 11 MMOL/L. CUSTOMER CHANGED THE BATTERY BUT THE ANOMALY PERSISTED. CUSTOMER STATED THAT BUTTONS WERE NOT PRESSED FOR LONGER THAN 3 MINUTES. PUMP WAS NOT BUMPED OR DROPPED. PUMP WILL BE RETURNED FOR ANALYSIS AND WILL BE REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
355344	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