BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3170647 · Received June 14, 2013

    Report

    Report Number
    2954323-2013-00340
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 12, 2013
    Product Code
    NBW
    PMA / PMN Number
    K111874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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 THE FOLLOWING: "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." INCORRECTLY STATED THE DATE OF 6/28/2013 THE DATE SHOULD BE 07/02/2013. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    RETURNED METER POWERED ON WITH BUTTON. METER DID NOT POWER ON WITH INSERTION OF TEST STRIPS. IN ADDITION TO INVESTIGATION WITH RETURNED METER AND RETURNED TEST STRIPS, INVESTIGATION WAS ALSO DONE UTILIZING RETAINED TEST STRIPS LOT NUMBER 1254223 AND RETAINED METER SERIAL NUMBER (B)(4). THE ISSUE WAS CONFIRMED, POWER ISSUE WITH STRIP PORT WAS OBSERVED-RAISED PIN #6 IN STRIP PORT. INVESTIGATION HAS 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.

    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.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THAT CUSTOMER (HER DAUGHTER) WAS UNABLE TO OBTAIN HER BLOOD GLUCOSE READING DUE TO HER METER NOT TURNING ON UPON INSERTION OF THE TEST STRIP. IT WAS FURTHER REPORTED THAT CUSTOMER HAD A LOSS OF CONSCIOUSNESS AND A SEIZURE. CUSTOMER'S MOTHER TREATED HER WITH GLUCOSE GEL THAT WAS RUBBED ON HER GUMS. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTH CARE FACILITY, RECEIVED A DIAGNOSIS OF HYPOGLYCEMIA AND WAS TREATED WITH INTRAVENOUS GLUCOSE. CUSTOMER ALSO RECEIVED NEW MEDICATIONS- UNSPECIFIED "ANTI-SICKNESS" MEDICATIONS AND PARACETAMOL INTRAVENOUSLY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272082 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW 1358112

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| O| R