FDA Adverse Event Malfunction Summary report: N

530G INSULIN PUMP

MDR report key: 4241571 · Received November 10, 2014

Report

Report Number: 2032227-2014-50030
Event Type: Malfunction
Date Received: November 10, 2014
Date of Event: October 13, 2014
Report Date: October 13, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OZO
PMA / PMN Number: 120010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PATIENT

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. THIS MDR RELATED TO THE (B)(4)MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP ALARMED LOW BATTERY AND SHUT OFF. CUSTOMER STATED THEY COULD NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM, BUT THEIR BLOOD GLUCOSE LEVELS WERE HIGH. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SHOW PHYSICAL DAMAGE AND CUSTOMER STATED IT DOES NOT. NEXT, CUSTOMER WAS ASKED IF THE BATTERY COMPARTMENT APPEARED DAMAGED. CUSTOMER STATED IT DOES NOT. AFTERWARDS, CUSTOMER WAS ADVISED TO CLEAN BATTERY CAP WITH COTTON SWAB AND REINSERT BATTERIES. CUSTOMER STATED DEVICE DISPLAY RETURNED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
722578	530G INSULIN PUMP	OZO	OZO	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-751NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR