BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3053030 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07595
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 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
    VA, 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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATE HIGH READING OF "115 MG/DL" WITH THE SUBJECT METER ON AN UNSPECIFIED DATE/TIME. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION(S) AND DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE HIGH RESULT. HOWEVER, THE PATIENT REPORTED DEVELOPING SYMPTOM OF "SWEATING" LATER THAT DAY AND TREATING SELF WITH FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE PATIENT ALSO REPORTED THAT THE CODE NUMBER ON THE SUBJECT METER WAS INCORRECT. THE CCA ASSISTED THE PATIENT WITH CHANGING THE METER¿S CODE NUMBER. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156569 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3394329

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R