BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2853855 · Received December 3, 2012

    Report

    Report Number
    3008382007-2012-07015
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. SINCE TEST STRIP LOT NUMBER WAS NOT PROVIDED, PA UNABLE TO PERFORM TEST STRIP LOT EVALUATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. TEST STRIP LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT'S WIFE (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT HER HUSBAND'S ONETOUCH ULTRAMINI METER WAS DISPLAYING AN ERROR 3 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). IT IS NOT KNOWN WHEN THE ALLEGED METER ISSUE FIRST BEGAN. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE REPORTER STATED THE PATIENT ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, THE REPORTER DENIED THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. THE REPORTER ALSO DENIED THE PATIENT TESTED HIS BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE OCCURRED. AS A RESULT OF THE ALLEGED METER ISSUE, THE REPORTER CLAIMED THE PATIENT DEVELOPED A SYMPTOM OF SHAKING AT AN UNKNOWN TIME LATER AND ACCORDING TO THE REPORTER, THE PATIENT CONSUMED FOOD AND/OR DRINK AS SELF-TREATMENT AT AN UNCLEAR TIME AFTERWARDS. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE PROPER TESTING PROCEDURE (PER OWNER'S BOOKLET RECOMMENDATION) AND NOTED THAT THE REPORTER DID NOT HAVE ALL OF THE PATIENT'S TESTING SUPPLIES AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS HER HUSBAND WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND HE REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA 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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R