BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2851539 · Received November 29, 2012

    Report

    Report Number
    3008382007-2012-06896
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 8, 2012
    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
    PA, 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) 2012, THE LAY USER/ REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING HIS ONETOUCH ULTRA2 METER WAS NOT POWERING WHEN ON HE TRIED TO TEST HIS BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED, THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2012 AT 6PM. THE REPORTER STATED, THE PATIENT USES SELF ADJUSTING NOVOLOG AND LEVEMIR INSULIN TO MANAGE HIS DIABETES AND NORMALLY TESTS TWICE A DAY. THE REPORTER STATED ON (B)(6) 2012 THROUGHOUT THE DAY, THE PATIENT ADMINISTERED 30 UNITS OF NOVOLOG INSULIN AND 16 UNITS OF LEVEMIR INSULIN. THE REPORTER STATED 10 MINUTES LATER, THE PATIENT LOSS CONSCIOUSNESS. IT IS UNCLEAR IF THE PATIENT REGAINED CONSCIOUSNESS ON HIS OWN OR REQUIRED ASSISTANCE FROM A THIRD PARTY. THE REPORTER STATED, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM OR HOSPITAL ON (B)(6) 2012 BETWEEN 7-8PM AND WAS GIVEN IV GLUCOSE. THE REPORTER STATED THE PATIENT'S BLOOD GLUCOSE WAS MEASURED ON A LAB DRAW AND A READING OF "800MG/DL" WAS OBTAINED. IT IS UNCLEAR IF THE READING WAS PRIOR TO OR AFTER THE IV GLUCOSE WAS ADMINISTERED. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THERE WAS NO MISUSE OF THE METER AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. WHEN A NEW TEST STRIP WAS INSERTED, THE METER DID NOT TURN ON. THE PATIENT WAS FOUND TO BE USING THE CORRECT TEST STRIPS. WHEN THE POWER BUTTON WAS PRESSED, THE METER DID NOT TURN ON. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE REPORTER CLAIMS, DUE TO THE ALLEGED ISSUE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3352194

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R