BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3830514 · Received May 23, 2014

    Report

    Report Number
    2954323-2014-00582
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Removal / Correction Number
    ADC FA1002-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. ADDITIONALLY, THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. BASED ON THE INFORMATION REPORTED, IT IS UNKNOWN IF THE CUSTOMER SELF-ADMINISTERED BOTH INSULIN AND GLUCAGON. IT SHOULD ALSO BE NOTED THAT THE CUSTOMER REPORTED RECEIVING THE INFORMATION ABOUT THE FIELD ACTION APPROXIMATELY 1 MONTH PRIOR TO HIS MEDICAL EVENT, AND STATED THAT ALTHOUGH HE DOUBTED HIS TEST RESULTS, HE CONTINUED TO TEST USING HIS OMNIPOD METER AND FS LITE TEST STRIPS AND PROCEEDED TO SELF-TREAT ON THE RESULTS RECEIVED. FREESTYLE LITE TEST STRIPS ARE NOT COMPATIBLE WITH THE OMNIPOD SYSTEM. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE OMNIPOD SYSTEM WAS PROVIDING QUESTIONABLE READINGS WHEN USED WITH FREESTYLE LITE TEST STRIPS. CUSTOMER FURTHER REPORTED HE SELF-TREATED WITH INSULIN AND SELF-INJECTED GLUCAGON BASED ON THE READINGS HE RECEIVED AND SUBSEQUENTLY "GOT SICK". NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AS HE DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308090 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention