BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3230411 · Received July 16, 2013

    Report

    Report Number
    2954323-2013-00378
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 18, 2013
    Product Code
    NBW
    PMA / PMN Number
    K111874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND TESTED WITH RETAINED TEST STRIPS OF A DIFFERENT LOT. THE METER POWERED ON WITH BUTTON DEPRESSION BUT NOT WITH TEST STRIP INSERTION. METER WAS DISASSEMBLED AND PIN #6 IN THE TEST STRIP PORT WAS OBSERVED TO BE RAISED. INVESTIGATION DETERMINED THAT THE CUSTOMER CAN RAISE OR DAMAGE PIN #6 IF THE CUSTOMER MISHANDLES THE TEST STRIP PRIOR TO INSERTION. THE INSTRUCTIONS FOR USE STATE, "DO NOT BEND, CUT OR ALTER TEST STRIPS" AND PROVIDES INSTRUCTIONS ON WHAT TO DO IF THE TEST DOES NOT START, SUCH AS TRYING A DIFFERENT STRIP, USING AN ALTERNATE METER OR CONTACTING THEIR HCP. THE ISSUE WAS CONFIRMED. POWER ISSUE WITH STRIP PORT WAS OBSERVED DUE TO RAISED PIN #6 IN STRIP PORT. GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER EXTENDED INVESTIGATION, IT HAS BEEN DETERMINED THAT THE STRIP PORT WAS DAMAGED BY THE INSERTION OF A BENT TEST STRIP; THEREFORE, THE ISSUE IS NOT CONFIRMED DUE TO USE. NOTE: A REVIEW OF THE INTERNAL MEMORY LOG INDICATED THAT THE CUSTOMER WAS ABLE TO RECEIVE READINGS ON THE DAY OF THE EVENT AND AFTER THE EVENT. FOLLOW-UP #1 INCORRECTLY STATED "USING AN ALTERNATE METER OR CONTACTING THEIR HCP " WHEN IT SHOULD SAY THAT LABEL COPY STATES "CONTACT YOUR HEALTH CARE PROFESSIONAL BEFORE TAKING ANY ACTION BASED ON AN UNCLEAR MESSAGE OR RESULT." THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO HIS ADC BLOOD GLUCOSE METER TURNING ON WITH BUTTON PRESS BUT NOT WITH TEST STRIP INSERTION. CUSTOMER FURTHER REPORTED THAT ON THE MORNING OF (B)(6) 2013 WHILE WATCHING TELEVISION HE EXPERIENCED SYMPTOMS DESCRIBED AS "SHAKING, FELT VERY DISORIENTED, FELT VERY WEAK, GOT BLURRY VISION, AND DIZZINESS". CUSTOMER DENIED SELF-TREATMENT AND SELF-PRESENTED TO A DOCTOR WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND ADMINISTERED AN "INSULIN SHOT AND AN INSULIN DRIP". CUSTOMER COULD NOT RECALL THE NAME OF THE MEDICATION NOR THE DOSAGE THAT WAS ADMINISTERED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327871 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW 1265341

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention