BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 3944844 · Received July 18, 2014

    Report

    Report Number
    2954323-2014-00780
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 11, 2013
    Report Date
    June 25, 2014
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    PMA / PMN Number
    K092638
    Removal / Correction Number
    ADC FA1002-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 (B)(4)) AND AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING (B)(4) 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 DEVICE MANUFACTURE DATE FOR THE REPORTED TEST STRIP LOT NUMBER IS UNKNOWN. THE DATE ENTERED IS THE COMPLAINT AWARENESS DATE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A FOLLOW-UP REPORT TO REPORT ADDITIONAL INFORMATION RECEIVED BY THE INITIAL CALLER ON (B)(6) 2014. LABORATORY GLUCOSE AND URINALYSIS RESULTS HAVE BEEN INCLUDED. OMNIPOD BLOOD GLUCOSE RESULTS HAVE BEEN INCLUDED.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A FOLLOW-UP REPORT TO REPORT ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014. THE LOT NUMBER OF THE FREESTYLE TEST STRIP REPORTED BY THE CUSTOMER IS LOT # 1285220. THE TEST STRIP LOT HAS BEEN INCLUDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, CUSTOMER RECEIVED VARIOUS READINGS ON THEIR OMNIPOD SYSTEM RANGING FROM 88 MG/DL TO 244 MG/DL. ON (B)(6) 2014, WHILE IN THE HOSPITAL, THE CUSTOMER RECEIVED READINGS RANGING FROM 40 MG/DL TO 398 MG/DL.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S MOTHER) REPORTED THAT THE OMNIPOD SYSTEM, WHEN USED WITH UNSPECIFIED FREESTYLE TEST STRIPS, WAS PROVIDING READINGS THAT WERE LOWER THAN THE CUSTOMER FELT. CALLER FURTHER REPORTED THAT ON THE EVENING OF (B)(6) 2013, THE CUSTOMER DID NOT FEEL WELL AND EXPERIENCED VOMITING. SYMPTOMS PERSISTED THE NEXT DAY, (B)(6) 2013, AND THE CUSTOMER WAS TAKEN TO A HOSPITAL WHERE HE WAS DIAGNOSED WITH "MILD DIABETIC KETOACIDOSIS (DKA)" AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION. CUSTOMER COULD NOT RECALL ANY ADC METER, LAB, OR HCP METER READINGS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423028 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. 1285220

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention