BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3183527 · Received June 22, 2013

    Report

    Report Number
    3008382007-2013-17999
    Event Type
    Injury
    Date Received
    June 22, 2013
    Report Date
    May 31, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH ULTRA2 METER WAS NOT POWERING ON WHEN SHE TRIED TO TEST HER BLOOD GLUCOSE. THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED, THE ALLEGED ISSUE FIRST OCCURRED DURING (B)(6) (UNKNOWN YEAR) AROUND NOON. THE REPORTER STATED THE PATIENT USES ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HER DIABETES. THE REPORTER STATED ON AN UNKNOWN DATE AND TIME, THE PATIENT EXERCISED MORE THAN USUAL. THE REPORTER STATED AT AN UNKNOWN TIME, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIZZINESS AND SHAKY.¿ THE REPORTER STATED ON (B)(6) 2013 AT 11AM, THE PATIENT WAS SEEN IN A DOCTOR¿S OFFICE OR CLINIC AND AN UNKNOWN READING WAS OBTAINED. THE REPORTER STATED THE PATIENT WAS GIVEN METFORMIN 1000MG AS TREATMENT. IT IS UNCLEAR IF THIS WAS A CHANGE IN THE PATIENT¿S NORMAL DIABETES MEDICATION OR A TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TEST STRIPS. WHEN A NEW TEST STRIP WAS INSERTED THE METER DID NOT TURN ON. WHEN THE POWER BUTTON WAS PRESSED, THE METER DID NOT TURN ON. IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE SUBJECT METER. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284296 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3436476

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R