BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 4091022 · Received September 16, 2014

    Report

    Report Number
    2939301-2014-24202
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 4, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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) 2014, THE LAY USER/ PATIENT¿S SISTER CONTACTED LIFESCAN (LFS) (B)(4) ON BEHALF OF THE PATIENT, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HER FEELING AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER CLAIMED THAT ON (B)(6) 2014 AT 7:30AM THE PATIENT OBTAINED AN INACCURATE HIGH BLOOD GLUCOSE RESULT OF ¿170 MG/DL¿. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER) AND SHE TESTS HER BLOOD GLUCOSE TWICE A DAY. THE REPORTER CLAIMED ADMINISTERING 28 UNITS OF MIXTARD INSULIN TO HER SISTER BASED ON THE ALLEGED INACCURATE RESULT AND 10 MINUTES LATER THE REPORTER CLAIMED THE PATIENT DEVELOPED ¿HYPOGLYCEMIC¿ SYMPTOMS DESCRIBED AS ¿DIZZINESS, SWEATINESS, TREMBLING, AND FEELING FAINT.¿ THE REPORTER CLAIMED SHE GAVE THE PATIENT A SMALL CANDY IN RESPONSE TO THE SYMPTOMS AND THE PATIENT FELT BETTER ALMOST INSTANTLY. THE REPORTER CLAIMED NO OTHER BLOOD GLUCOSE TESTS WERE PERFORMED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR WALKED THROUGH A CONTROL SOLUTION TEST AND THE RESULT WAS WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, WAS ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570999 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3530562

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R