BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6176425 · Received December 15, 2016

    Report

    Report Number
    3008382007-2016-64289
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 20, 2016
    Report Date
    December 7, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA 2 METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HIS FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE SUBJECT METER WAS READING INACCURATELY AT 07:30AM ON (B)(6) 2016 WHEN HE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF ¿143, 139, 148, 142 AND 147 MG/DL¿. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER). HE REPORTED THAT, HE INCREASED HIS DOSE OF LANTUS INSULIN TO 60 UNITS AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT AT 8:15AM HE DEVELOPED THE SYMPTOMS OF SHAKY AND SWEATING. AT 08:30AM THE PATIENT SELF-TREATED WITH A GLUCOSE TABLET. THE PATIENT DENIED USING ANOTHER DEVICE TO OBTAIN A BLOOD GLUCOSE RESULT. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. HE ALSO CONFIRMED THAT HIS TEST STRIPS WERE WITHIN EXPIRY DATE AND HAD BEEN STORED CORRECTLY. THE PATIENT PERFORMED A CONTROL SOLUTION TEST AND THE RESULT FELL WITH LFS¿ ACCEPTABLE RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828189 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3892033 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening