FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 3841664 · Received May 30, 2014

Report

Report Number: 2032227-2014-02172
Event Type: Malfunction
Date Received: May 30, 2014
Date of Event: May 24, 2014
Report Date: May 24, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UP ARROW BUTTON NO RESPONSE DUE TO KEYPAD CONNECTOR NOT PLUGGED IN PROPERLY. NO FROZEN SCREEN NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS, SCRATCHED LCD WINDOW AND MISSING END CAP STICKER.

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 THE PUMP HAD A FROZEN SCREEN AND UNRESPONSIVE BUTTONS. IT WAS STATED THAT THE TIME ON THE SCREEN WAS NOT ADVANCING. THE PATIENT WAS GETTING A CHECK BG ALERT, BUT COULD NOT CLEAR IT. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NOT RESOLVED. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
318236	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-554LCMP

Patients

Seq	Age	Sex	Outcome	Treatment
1