BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4091151 · Received September 16, 2014

    Report

    Report Number
    2939301-2014-24323
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    September 8, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) VIA CORRESPONDENCE LETTER ALLEGING THAT THE ONETOUCH ULTRALINK METER READ INACCURATELY. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DOES NOT SPECIFY WHEN THE ALLEGED METER ISSUE FIRST BEGAN. AT UNSPECIFIED DATES/TIMES THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿144, 141, 137, 152, AND 164MG/DL¿ WITH THE SUBJECT METER. THE PATIENT¿S DIABETES REGIMEN IS NOT KNOWN AND IT IS NOT SPECIFIED WHAT ACTION THE PATIENT TOOK IN REGARDS TO HIS DIABETES REGIMEN AFTER THE REPORTED ISSUE OCCURRED. THE PATIENT DOES NOT SPECIFY DEVELOPING SYMPTOM(S) AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, INDICATED AS A RESULT OF THE PRODUCT ISSUE HE WAS HOSPITALIZED FOR 24 HOURS AND HAD ALSO OBTAINED A READING WITH THE HOSPITAL¿S DEVICE THAT WAS ¿100 POINTS OFF¿. THE TYPE OF TREATMENT HE MAY HAVE RECEIVED DURING HIS TIME IN THE HOSPITAL IS NOT SPECIFIED. THE PATIENT NOTED HE PERFORMED THE QUALITY CONTROL TESTS MULTIPLE TIMES AND ALL TESTS PASSED. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY WAS HOSPITALIZED WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572797 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3363478

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization