FDA Adverse Event Malfunction Summary report: N

FREESTYLE LITE

MDR report key: 3853910 · Received June 6, 2014

Report

Report Number: 2954323-2014-00638
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: May 9, 2014
Report Date: May 11, 2014
Product Code: NBW
PMA / PMN Number: K092638
Removal / Correction Number: ADC FA1002-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE FREESTYLE TEST STRIP LOT THAT IS REFERENCED IN THIS MDR IS ASSOCIATED WITH AN ON-GOING RECALL. THE FDA WAS INFORMED OF THE FIELD ACTION PER 21CFR806 (RECALL NUMBER 2954323-02/07/14-001-R) AND AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING FEBRUARY 19, 2014. ADC HAS IDENTIFIED THAT ALL NON-APPLIED VOLTAGE LEGACY BLOOD GLUCOSE METERS (0MV) MAY PRODUCE ERRONEOUSLY LOW BLOOD GLUCOSE READINGS IN THE PARKES ERROR GRID C OR D ZONE THAT COULD POTENTIALLY AFFECT CLINICAL OUTCOME WHEN USED IN CONJUNCTION WITH FREESTYLE TEST STRIP LOT WITHIN EXPIRY. THIS ISSUE ONLY OCCURS WHEN FREESTYLE OR FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS ARE USED WITH FREESTYLE, FREESTYLE FLASH BLOOD GLUCOSE METERS AND THE FREESTYLE BLOOD GLUCOSE METER BUILT INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEM AND FREESTYLE NAVIGATOR. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: FREESTYLE LITE TEST STRIPS ARE NOT COMPATIBLE WITH FREESTYLE METERS.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT THEIR OMNIPOD SYSTEM HAD GIVEN A READING LOWER THAN THEY FELT WHILE USING FREESTYLE LITE TEST STRIPS. 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
332632	FREESTYLE LITE	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1377543

Patients

Seq	Age	Sex	Outcome	Treatment
1