BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 7295496 · Received February 26, 2018

    Report

    Report Number
    3008382007-2018-00631
    Event Type
    Injury
    Date Received
    February 26, 2018
    Report Date
    February 15, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT CODE FOR HEART POUNDING.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA 2 METER READ INACCURATELY HIGH AND LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO CONFIRM WHEN THE METER ISSUE BEGAN. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿204, 165, 250, 230, 135, 196, 221 AND 187 MG/DL¿ AND ¿196, 221 AND 187 MG/DL¿WITH THE SUBJECT METER, AND INACCURATE LOW BLOOD READINGS OF "58 AND 69 MG/DL. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. IT IS UNKNOWN HOW THE PATIENT MANAGES HIS DIABETES, BUT THE CSR NOTED THAT IN RESPONSE TO THE ALLEGED INACCURATE HIGH READINGS, THE PATIENT STATED THAT HE TOOK INSULIN. AT AN UNKNOWN TIME AFTER OBTAINING THE RESULTS, THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEATING, HEART POUNDING, AND CAN BARELY WALK¿. THERE IS NO EVIDENCE THE PATIENT RECEIVED ANY MEDICAL TREATMENT, BUT CSR NOTED AT THIS POINT, THE PATIENT ENDED THE CALL. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR WALKED THE REPORTER THROUGH A RETEST AND THE CONTROL SOLUTION TEST WAS IN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN. PLEASE REFER TO RELATED (B)(4). FOR ADDITIONAL INFORMATION INCLUDED IN THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138756 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4328361 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening