BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3220417 · Received July 11, 2013

    Report

    Report Number
    3008382007-2013-19309
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 28, 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
    NY, 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) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT 3 WEEKS PRIOR TO CONTACTING LFS. IT WAS REPORTED THE PATIENT OBTAINED RESULTS OF ¿500, 490, 400, 453, 349, 362, 367 AND 415 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT ALSO COMPARED THE SUBJECT METER WITH ANOTHER DEVICE. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿490 MG/DL¿ WITH THE SUBJECT METER AND ¿350 MG/DL¿ ON THE OTHER METER, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). IT IS NOT CLEAR HOW THE PATIENT MANAGES HIS DIABETES OR IF CHANGES WERE MADE TO HIS USUAL MANAGEMENT ROUTINE. IMMEDIATELY AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF WEAKNESS AND SWEATING. THE PATIENT TOOK MORE FOOD AND/ OR DRINK (HONEY). THE PATIENT WAS REPORTEDLY ALSO TAKEN TO THE EMERGENCY ROOM (ER) THAT SAME DAY. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿57 MG/DL¿ WITH THE ER/ HOSPITAL METER. TREATMENT WAS NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. 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 DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321077 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3472534

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R