BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3020480 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06262
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 13, 2013
    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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4)) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED 2 MONTHS PRIOR TO CONTACTING LFS, BUT CLAIMED THE POWER ISSUE WAS INTERMITTENT. IT WAS NOTED THAT THE PATIENT STATED IT WOULD SOMETIMES WORK AFTER SEVERAL ATTEMPTS. THE PATIENT INFORMED THE CSR THAT HE TESTS HIS BLOOD GLUCOSE 3-4 TIMES A DAY AND MANAGES HIS DIABETES WITH ORAL MEDICATIONS. THE PATIENT MENTIONED THAT HE ADJUSTS THE AMOUNT OF "NOVO-GLYBURIDE" PILLS HE TAKES BASED ON HIS FEELINGS AND HIS BLOOD GLUCOSE RESULTS. THE PATIENT CONFIRMED HE'S MADE THIS ADJUSTMENT ON HIS OWN ACCORD, WITHOUT THE ADVICE/RECOMMENDATION FROM HIS HCP. ON AN UNSPECIFIED DATE/TIME, AFTER THE ALLEGED METER ISSUE STARTED, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF FEELING "SHAKY, SWEATY AND NOT FEELING WELL". THE PATIENT CONFIRMED HE ASSOCIATED THE SYMPTOMS WITH A LOW GLUCOSE AND TREATED SELF WITH FOOD. THE PATIENT CONFIRMED FEELING BETTER AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT HAD NOT REPLACED THE SUBJECT METER'S BATTERY AS RECOMMENDED IN THE OWNER'S BOOKLET. THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THE SUBJECT METER WAS REQUESTED BACK. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123826 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3283743

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R