BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2873213 · Received December 13, 2012

    Report

    Report Number
    2954323-2012-06769
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND TESTED WITH RETURNED TEST STRIPS. NO NEW ISSUES WERE OBSERVED. DISASSEMBLED METER AND OBSERVED BLOCKAGE OF A PIECE OF PAPER IN THE STRIP PORT. REMOVED PAPER FROM STRIP PORT. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. DID NOT OBSERVE TDN-3 ISSUE. THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2012 HE WAS EXPERIENCING UNSPECIFIED "LOW BLOOD GLUCOSE" SYMPTOMS SO HE CALLED HIS SON TO ASSIST WITH A BLOOD TEST. HOWEVER, THE TEST DID NOT START ON HIS ADC BLOOD GLUCOSE METER AFTER A SAMPLE WAS APPLIED TO A TEST STRIP INSERTED INTO IT. IT WAS FURTHER REPORTED THAT DUE TO THIS CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER WAS GIVEN FRUIT PUNCH, SWEET TEA AND AN UNSPECIFIED NUMBER OF GLUCOSE TABLETS TO INGEST BY HIS SON. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1271509

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R