BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4431421 · Received January 20, 2015

    Report

    Report Number
    2939301-2015-02097
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 16, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CANADA ALLEGING THAT THEIR ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE FIRST OCCURRED AT 6PM ON (B)(6) 2015. AT THIS TIME THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿20.2MMOL/L¿ WITH THE SUBJECT METER, SO SELF-ADJUSTED THEIR INSULIN INTAKE BY TAKING ¿20 UNITS OF HUMALOG.¿ THEN, AT 8PM THE SAME EVENING, THE PATIENT MEASURED THEIR BLOOD GLUCOSE AGAIN ON THE SUBJECT METER AND OBTAINED A RESULT OF ¿20.0MMOL/L¿, SO TOOK A FURTHER ¿14 UNITS OF HUMALOG.¿ ONCE AGAIN, AT 10PM, THE PATIENT MEASURED THEIR BLOOD GLUCOSE ON THE SUBJECT METER AND OBTAINED A RESULT OF ¿17.0MMOL/L¿, SO TOOK ANOTHER ¿10 UNITS OF HUMALOG INSULIN.¿ AT 3:45AM THE FOLLOWING MORNING THE PATIENT WOKE UP FEELING ¿HOT¿ AND THEIR STOMACH WAS ¿CHURNING¿. AT 5:45AM THE EMERGENCY MEDICAL TECHNICIANS (EMT) ARRIVED AT THE PATIENT¿S HOME AND THE PATIENT WAS REVIVED BY THEM. IT IS NOT KNOWN IF THE PATIENT HAD BEEN UNCONSCIOUS, NOR HOW THE EMTS WERE ALERTED TO THE EVENT. THE PATIENT RECEIVED A GLUCAGON INJECTION FROM THE EMTS AND THEIR BLOOD GLUCOSE WAS MEASURED ON AN EMT METER WITH A RESULT OF ¿1.3MMOL/L¿ BEING OBTAINED. AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THAT THE CORRECT UNIT OF MEASURE WAS SET ON THE SUBJECT METER AND THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS TO HAVE OBTAINED INACCURATELY HIGH READINGS ON THE SUBJECT METER WHICH LED TO THEM SUFFERING SYMPTOMS WHICH ARE SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN. ADDITIONALLY, THE PATIENT RECEIVED TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR THESE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47066 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3672107

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R