BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2874909 · Received December 16, 2012

    Report

    Report Number
    3008382007-2012-08282
    Event Type
    Injury
    Date Received
    December 16, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 2PM. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "109 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE AT THE TIME OF THE ALLEGED ISSUE; HOWEVER, EARLIER THAT SAME MORNING, THE PATIENT REPORTEDLY ADMINISTERED SELF HIS USUAL DOSE OF INSULIN (35 UNITS). IMMEDIATELY AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS HE FELT SYMPTOMS OF SWEATS AND SHAKY. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. AT THAT TIME, THE PATIENT ALSO TESTED ON ANOTHER DEVICE AND OBTAINED A BLOOD GLCUOSE RESULT OF "129 MG/DL." AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3320182

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R