FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP

MDR report key: 5371662 · Received January 15, 2016

Report

Report Number: 3004209178-2016-82413
Event Type: Malfunction
Date Received: January 15, 2016
Date of Event: February 10, 2014
Report Date: September 10, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN PROVIDED WHICH WAS NOT INCLUDED WITH THE INITIAL MEDWATCH REPORT. THE ADDITIONAL INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

Additional Manufacturer Narrative · 1

DEVICE RECEIVED WITH BLANK DISPLAY DUE TO BROKEN SOLDER JOINT ON INTERFACE BOARD. UNABLE TO CONFIRM BUTTON ERROR ALARM DUE TO BLANK DISPLAY HOWEVER CORRODED KEYPAD TRACES NOTED DURING VISUAL INSPECTION. DEVICE RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

Description of Event or Problem · 1

IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP ALARMED BUTTON ERROR AFTER A FINGER PRICK. THE CUSTOMER WAS OVERSEAS AND STATED THAT THE ALARM DID NOT OCCUR RIGHT AFTER THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE CUSTOMER STATED A BUTTON WAS NOT PRESSED FOR 3 MINUTES OR LONGER. THE CUSTOMER'S BLOOD GLUCOSE WAS 6.8MMOL/L.

Description of Event or Problem · 1

CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
28185	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722CAB

Patients

Seq	Age	Sex	Outcome	Treatment
1