FDA Adverse Event Injury Summary report: N

SENSOR ENLITE

MDR report key: 3930852 · Received July 12, 2014

Report

Report Number: 2032227-2014-03587
Event Type: Injury
Date Received: July 12, 2014
Date of Event: May 5, 2014
Report Date: June 12, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OZO
PMA / PMN Number: 120010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: DE
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.

Additional Manufacturer Narrative · 1

A COMPLETE ANALYSIS AND TESTING OF THE SENSOR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

Description of Event or Problem · 1

CUSTOMER HAVING ISSUES WITH THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CUSTOMER USES TWO DIFFERENT METERS. ADVISED CUSTOMER TO USE ONE METER. CUSTOMER ALSO STATED THAT SHE WAS HOSPITALIZED ONE MONTH AGO DUE TO HIGH BLOOD KETONES OF 20. CUSTOMER WAS HOSPITALIZED FOR THREE DAYS. THE BLOOD GLUCOSE READINGS WERE NOT HIGH. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
408668	SENSOR ENLITE	OZO	OZO	MEDTRONIC MINIMED	MMT-7008A	C174U

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR		Hospitalization