FDA Adverse Event Malfunction Summary report: N

SENSOR ENLITE

MDR report key: 3972409 · Received July 31, 2014

Report

Report Number: 2032227-2014-05158
Event Type: Malfunction
Date Received: July 31, 2014
Date of Event: July 1, 2014
Report Date: July 2, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OZO
PMA / PMN Number: 120010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR
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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

Description of Event or Problem · 1

CUSTOMER CALLED REPORTING LARGE DISCREPANCIES BETWEEN HER SENSOR GLUCOSE READINGS AND BLOOD GLUCOSE LEVELS. SHE STATED THE SENSOR WAS SHOWING 40 MG/DL, BUT SHE WAS ACTUALLY ABOVE 200 MG/DL. SHE CHARGED THE TRANSMITTER AND RECONNECTED IT TO THE SENSOR, BUT IT ALARMED CALIBRATION ERROR. CURRENTLY, CUSTOMER'S BLOOD GLUCOSE IS 73 MG/DL. THIS IS LOW FOR HER, BUT SHE HAS EATEN. SHE SAID THE LAST DISCREPANCY BETWEEN SENSOR GLUCOSE READINGS AND BLOOD GLUCOSE LEVEL WAS YESTERDAY, WHEN HER SENSOR READ 40 MG/DL BUT SHE WAS ACTUALLY 220 MG/DL. SENSOR WAS INSERTED ON (B)(6) 2014. THERE ARE NO ACTIVITIES CONNECTED TO THE EVENT. IN THE DATA TABLE, THE SENSOR WAS TRENDING WELL FROM THE INSERTION START UNTIL YESTERDAY, WHEN IT BEGAN TRENDING LOW FOR NO REASON. THE SENSOR WAS NOT PHYSICALLY DAMAGED. THE ALERT HISTORY SHOWED MULTIPLE SENSOR ERRORS. CUSTOMER IS CURRENTLY NOT WEARING THE SENSOR. THE TRANSMITTER WAS FUNCTIONING PROPERLY. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
446743	SENSOR ENLITE	OZO	OZO	MEDTRONIC MINIMED	MMT-7008A

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR