BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3871046 · Received June 13, 2014

    Report

    Report Number
    2939301-2014-14353
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 4, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH AND ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2014. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿212 MG/DL¿ AND ¿117, 192 AND 42 MG/DL¿ AND ¿100, 197 AND 217 MG/DL¿ WITH THE SUBJECT METER, PERFORMED AT UNSPECIFIED TIMES OF EACH OTHER. THE PATIENT DID NOT SPECIFY HOW HE MANAGES HIS DIABETES; HOWEVER, THE PATIENT REPORTEDLY ADMINISTERED HIMSELF INSULIN (TYPE/ AMOUNT NOT SPECIFIED). AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF LIGHT HEADEDNESS, SHAKINESS AND SWEATS. ADDITIONAL TREATMENT WAS NOT SPECIFIED. 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. QUALITY CONTROL TESTING WAS PERFORMED WHICH TESTED WITHIN SPECIFICATIONS. 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
    350627 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3481559

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening