BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3102223 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10755
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 24, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIOIQ METER POWERED OFF DURING USE AND THEN REVERTED TO THE SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE SUBJECT METER POWERED OFF DURING EITHER ON THE MORNING OR AFTERNOON OF (B)(6) 2013. THE PATIENT INFORMED THE CSR WHEN THE METER WAS POWERED BACK ON, IT REVERTED TO THE SETUP MODE. THE PATIENT INFORMED THE CSR THAT PRIOR TO WHEN SHE ATTEMPTED TO TEST WITH THE SUBJECT METER SHE HAD DEVELOPED SYMPTOMS OF "THIRST, NAUSEA AND A RED FACE". THE PATIENT STATED WHEN SHE WAS UNABLE TO OBTAIN A READING WITH THE SUBJECT METER SHE IMMEDIATELY TESTED ON ANOTHER DEVICE (ONETOUCH ULTRA2) AND OBTAINED A READING OF "24.0 MMOL/L (432 MG/DL)". THE PATIENT REPORTED THAT SHE TOOK EXTRA INSULIN IN RESPONSE TO THE ELEVATED RESULT AND SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE ALLEGED METER ISSUES REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUES CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT WAS SYMPTOMATIC PRIOR TO WHEN THE SUBJECT METER POWERED OFF AND REVERTED TO THE SETUP MODE. IN ADDITION, THERE IS NO EVIDENCE OF DELAY IN TREATMENT DUE TO THE METER ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER POWER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203486 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR