FDA Adverse Event Malfunction Summary report: N

SENSOR ENLITE

MDR report key: 3933480 · Received July 14, 2014

Report

Report Number: 2032227-2014-03813
Event Type: Malfunction
Date Received: July 14, 2014
Date of Event: June 14, 2014
Report Date: June 14, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OZO
PMA / PMN Number: 120010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

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.

Description of Event or Problem · 1

THE CUSTOMER CALLED IN TO REPORT THAT SHE HAD BEEN RECEIVING A LOST SENSOR ALARM ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL IS 125 MG/DL. THE CUSTOMER STATES THAT SHE ALSO HAD A SENSOR POP OUT OF HER SKIN. THE CUSTOMER STATES THAT WHEN SHE RECEIVED THE LOST SENSOR ALARM SHE WAS SITTING DOWN. DURING TROUBLESHOOTING WE ADVISED THE CUSTOMER OF THE PROPER TAPING TECHNIQUES AND WE TESTED THE TRANSMITTER AND IT FUNCTIONED PROPERLY. THE CUSTOMER FOUND OUT DURING TROUBLESHOOTING THAT THE SENSOR WAS BENT. WE ADVISED CUSTOMER TO CHANGE THE CURRENT SENSOR OUT. WE ADVISED THE CUSTOMER THAT THE SENSOR MAY NOT BE WORKING, DISLODGED, BENT, RETRACTED OR DAMAGED AND TO KEEP THE SENSOR FOR ANALYSIS. NO FURTHER INFORMATION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
411012	SENSOR ENLITE	OZO	OZO	MEDTRONIC MINIMED	MMT-7008A	HG03N6W

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR