BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3119777 · Received May 19, 2013

    Report

    Report Number
    3008382007-2013-12123
    Event Type
    Injury
    Date Received
    May 19, 2013
    Report Date
    April 30, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE ALLEGED ISSUE WAS NOT OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ONE MORNING IN (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿225, 103, 164 AND 218 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN AND HUMULIN INSULIN. THE PATIENT CONTINUED TO ADMINISTER HER USUAL DOSE OF MEDICATIONS. THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SWEATY, TIRED AND DIZZY. THE PATIENT REPORTEDLY OBTAINED A RESULT OF ¿65 MG/DL¿ WITH ANOTHER METER. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY MAY HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220648 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3331203

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R