BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2863825 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07504
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    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
    RI, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING THE ERROR 2, ERROR 3, ERROR 4 AND ERROR 5 ERROR MESSAGES. THE (B)(6) MEDICAL SURVEILLANCE (B)(6) WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012 AT 1:00 PM, THE PATIENT OBTAINED MULTIPLE ERROR MESSAGES, ERROR 2, ERROR 3, ERROR 4 AND ERROR 5 ON THE REPORTED METER; SHE DID NOT OBTAIN A BLOOD GLUCOSE READING. FIFTEEN MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF DIZZINESS, NOT FEELING WELL, AND SHE FELT "LOW". THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE CORRECT. THE PATIENT REFUSED TO COMPLETE THE TROUBLESHOOTING PROCESS, THEREFORE, NO INFORMATION WAS PROVIDED ABOUT THE CONDITION OR STORAGE OF THE TEST STRIPS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER ISSUES OCCURRED, AND RECEIVED TREATMENT WITH FOOD. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3297702

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R