FDA Adverse Event Malfunction Summary report: N

SENSOR ENLITE

MDR report key: 4862477 · Received June 23, 2015

Report

Report Number: 2032227-2015-19975
Event Type: Malfunction
Date Received: June 23, 2015
Date of Event: June 4, 2015
Report Date: June 4, 2015
Manufacturer: MEDTRONIC MINIMED
Product Code: OZO
PMA / PMN Number: 120010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA
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.

Description of Event or Problem · 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT HE HAD DIFFERENCES BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT THERE IS A LAG TIME BETWEEN THE ENLITE SENSOR AND HIS BLOOD GLUCOSE OF 10-15 MINUTES. CUSTOMER STATED THAT HIS SENSOR READ LOW AT 40 MG/DL BUT HIS BLOOD GLUCOSE WAS 120 MG/DL. CUSTOMER WAS ADVISED THAT IT IS NOT RECOMMENDED TO USE AN EXPIRED SENSOR. CUSTOMER STATED THAT HE WAS UNABLE TO UPLOAD TO CARELINK CURRENTLY. CUSTOMER PERFORMED THE TEST PLUG PROCEDURE AND PASSED. CUSTOMER STATED THAT HE JUST STARTED USING THE CONTINUOUS GLUCOSE MONITORING SYSTEM TODAY AND HE HAS NOT USED THE PUMP. CUSTOMER STATED THAT HE RECEIVED THE PUMP A YEAR AGO BUT IT HAS BEEN SITTING IN THE CLOSET FOR THE PAST YEAR. CUSTOMER ALSO HAD A SENSOR ERROR ALERT. CUSTOMER WAS ASSISTED WITH MAKING SURE THAT THE PUMP WAS COMMUNICATING WITH THE CONTINUOUS MONITORING SYSTEM. CUSTOMER WAS ADVISED TO REMOVE THE SENSOR AND THAT THE SENSOR WILL BE REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
407572	SENSOR ENLITE	OZO	OZO	MEDTRONIC MINIMED	MMT-7008A	HG0HSC4

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR