BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 7188773 · Received January 15, 2018

    Report

    Report Number
    3008382007-2018-00149
    Event Type
    Injury
    Date Received
    January 15, 2018
    Report Date
    January 10, 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
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER HUSBAND¿S ONETOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER WAS UNABLE TO CONFIRM WHEN THE ALLEGED METER INACCURACY BEGAN, BUT STATED THAT IT WAS ¿OVER A MONTH¿. THE REPORTER ALLEGED THE PATIENT OBTAINED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿238, 248, 152, 141, 103, 115, 271, 226, 223, 105, 151, 110, 113, 118, 117, 143, 135, 174, 115 AND 128 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE REPORTER WAS UNABLE TO CONFIRM HOW THE PATIENT MANAGES HIS DIABETES, BUT REPORTED THAT AFTER THE PRODUCT ISSUE (TIME UNKNOWN), THE PATIENT DEVELOPED SYMPTOMS OF ¿SLURRED SPEECH, CLAMMY, SWEATY, CONFUSED, PANICKY¿. IN RESPONSE TO THE ALLEGED SYMPTOMS, THE PATIENT TELEPHONED HIS NURSE, WHO RECOMMENDED HE ATTEND THE EMERGENCY DEPARTMENT. THE REPORTER AND HER HUSBAND, ATTENDED THE EMERGENCY ROOM, BUT THE WAIT WAS TOO LONG, AND THEY LEFT PRIOR TO ANY TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, WERE WITHIN EXPIRY DATE. THE CSR WALKED THE REPORTER THROUGH A RETEST AND THE CONTROL SOLUTION TEST WAS NOT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33832 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4270529 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening