BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 5610777 · Received April 27, 2016

    Report

    Report Number
    2939301-2016-20471
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    April 13, 2016
    Report Date
    April 18, 2016
    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
    CA, 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) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THAT THE METER BEGAN TO READ INACCURATELY AT 12:15AM ON (B)(6) 2016 WHEN SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF ¿152, 120 AND 132 MG/DL.¿ METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT DOES NOT ADMINISTER MEDICATION TO MANAGE HER DIABETES. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE ALLEGED INACCURATE RESULTS. SHE REPORTED THAT 20 MINUTES AFTER THE START OF THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS OF ¿FAST HEARTBEAT [AND] SHAKING.¿ SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THAT HER TEST STRIPS HAD BEEN STORED CORRECTLY AND HER METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH RESULTS WITH THE SUBJECT METER AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266076 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3942515

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening