BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3083922 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09566
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE CAPACITOR C19 DEFECTIVE AND A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN IN (B)(6), EXACT DATE/TIME UNKNOWN. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH LANTUS INSULIN 45 UNITS IN THE EVENINGS AND JANUMET PILLS 2X PER DAY AND HE DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. HE CLAIMED THAT APPROXIMATELY ONE MONTH LATER, HE DEVELOPED SYMPTOMS OF "EXCESSIVE URINATION AND WAS TIRED." HE DENIED RECEIVING ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE ALLEGED ISSUE REMAINED UNRESOLVED AND THE PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184114 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3238270

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening