FDA Adverse Event Malfunction Summary report: N

FREESTYLE

MDR report key: 3830475 · Received May 23, 2014

Report

Report Number: 2954323-2014-00579
Event Type: Malfunction
Date Received: May 23, 2014
Date of Event: April 30, 2014
Report Date: April 30, 2014
Product Code: LFR
PMA / PMN Number: K092602
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 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: FREESTYLE LITE TEST STRIPS ARE NOT COMPATIBLE WITH THE FREESTYLE METER. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

Description of Event or Problem · 1

CUSTOMER REPORTED RECEIVING A READING ON HIS FREESTYLE METER WHILE USING FREESTYLE LITE TEST STRIPS THAT WAS LOWER THAN AN UNSPECIFIED HOSPITAL READING. THERE WAS NO DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308842	FREESTYLE	BLOOD GLUCOSE MONITORING SYSTEM	LFR			1375644

Patients

Seq	Age	Sex	Outcome	Treatment
1