FDA Adverse Event Malfunction Summary report: N

FREESTYLE NAVIGATOR

MDR report key: 2870685 · Received December 12, 2012

Report

Report Number: 2954323-2012-06764
Event Type: Malfunction
Date Received: December 12, 2012
Date of Event: November 28, 2012
Report Date: November 28, 2012
Product Code: LFR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION WAS PERFORMED ON THE RETURNED PRODUCT. VISUAL INSPECTION ON THE TRANSMITTER IDENTIFIED A CRACK AT THE THERMISTOR BARREL. LEAK TESTING WAS THEN PERFORMED TO TEST THE NAVIGATOR TRANSMITTER FOR ACCEPTABLE PRESSURE DECAY (IE: LEAK RATE) OF THE SEALED UNIT. RETURNED TRANSMITTER ((B)(4)) FAILED THE LEAK TEST. REMEDIAL ACTION 2954323-04/14/2009-002-C, WAS REPORTED (B)(4) 2009. ADDITIONAL EVALUATION METHOD: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

Description of Event or Problem · 1

WHILE PERFORMING AN INVESTIGATION ON THE RETURNED FREESTYLE NAVIGATOR TRANSMITTER, A THERMISTOR CRACK WAS OBSERVED. IT HAS BEEN DETERMINED THAT SOME FREESTYLE NAVIGATOR TRANSMITTERS COULD POTENTIALLY EXHIBIT A CRACK/FRACTURE ON THE PLASTIC HOUSING NEAR THE BATTERY COMPARTMENT, WHICH COULD POTENTIALLY ALLOW MOISTURE TO COME IN CONTACT WITH THE TRANSMITTER'S INTERNAL ELECTRONICS, POTENTIALLY CAUSING THE TRANSMITTER AND THE RECEIVER TO LOSE CONNECTION INTERRUPTING THE CONTINUOUS GLUCOSE RESULTS. ALTHOUGH UNLIKELY, MOISTURE ENTERING THE TRANSMITTER HAS THE POTENTIAL TO GENERATE INACCURATE RESULTS ONLY WITH THE CONTINUOUS GLUCOSE READINGS. THE BUILT-IN FREESTYLE GLUCOSE METER IS NOT IMPACTED BY THIS ISSUE AND THE USER CAN CONTINUE TO USE THE BUILT-IN METER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FREESTYLE NAVIGATOR	CONTINUOUS GLUCOSE MONITORING SYSTEM	LFR

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR