FDA Adverse Event Malfunction Summary report: N

FREESTYLE

MDR report key: 3881473 · Received June 18, 2014

Report

Report Number: 2954323-2014-00673
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: May 23, 2014
Report Date: May 23, 2014
Product Code: LFR
PMA / PMN Number: K092638
Removal / Correction Number: ADC FA1002-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE FREESTYLE TEST STRIP LOT THAT IS REFERENCED IN THIS MDR, ALTHOUGH UNKNOWN, 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. NOTE: THE TEST STRIP LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURER DATE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

Description of Event or Problem · 1

A DISTRIBUTOR REPORTED RECEIVING LOW READINGS ON A ADC METER WHEN USED WITH UNSPECIFIED FREESTYLE BRAND TEST STRIPS. THERE WAS NO DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357829	FREESTYLE	BLOOD GLUCOSE MONITORING SYSTEM	LFR			UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1