FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 4850873 · Received June 17, 2015

Report

Report Number: 3004209178-2015-65897
Event Type: Malfunction
Date Received: June 17, 2015
Date of Event: May 28, 2015
Report Date: May 28, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NO
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

ALL BUTTONS FUNCTIONED PROPERLY. HOWEVER, THE INSULIN PUMP HAD CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. THE INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREAD, CRACKED RESERVOIR TUBE LIP, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED ON DISPLAY WINDOW, AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED.

Description of Event or Problem · 1

A NURSE REPORTED VIA PHONE CALL INDICATING THAT A CUSTOMER'S INSULIN PUMP ALARMED BUTTON ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE CALL. THE NURSE WAS NOT ABLE TO ERASE THE ALARM. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
393107	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