BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3072169 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08696
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 4, 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 WHEN POWERED BACK ON IT HAD REVERTED TO THE SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE OCCURRED 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED THAT JUST PRIOR TO ATTEMPTING TO TEST WITH THE SUBJECT METER SHE HAD DEVELOPED SYMPTOMS OF "BLURRY VISION, LETHARGY AND THIRST". THE PATIENT STATED WHEN SHE WAS UNABLE TO OBTAIN A READING WITH THE SUBJECT METER, SHE THEN TESTED HERSELF WITH HER FREESTYLE METER AND OBTAINED A READING OF "33.5 MMOL/L (603 MG/DL)". IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED IN RESPONSE TO THE SYMPTOMS AND ELEVATED RESULT OBTAINED ON THE OTHER DEVICE. AT THE TIME OF THE CALL, THE PATIENT CLAIMED SHE SAW HER ENDOCRINOLOGIST (DATE UNKNOWN) AND WAS ADVISED TO INCREASE HER LANTUS INSULIN DOSE FROM 12 UNITS TO 18 UNITS AND TO CONTINUE TAKING HER HUMALOG INSULIN BASED ON HER SLIDING SCALE. AT THE TIME OF THE CALL, THE PATIENT INFORMED THE CSR THAT SHE WAS TAKING PREDNISOLONE AT THE TIME OF THE INCIDENT, WHICH MAY HAVE CONTRIBUTED TO THE ELEVATED BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE ALLEGED METER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA, THERE IS NO INDICATION THAT THE ALLEGED METER ISSUE CAUSED AND/OR CONTRIBUTED TO THE PATIENT'S SERIOUS INJURY. THE PATIENT REPORTED THAT SHE FELT SYMPTOMATIC PRIOR TO WHEN THE ALLEGED METER ISSUE BEGAN. THEREFORE THE ALLEGED METER ISSUE DID NOT CONTRIBUTE TO THE PATIENT'S SYMPTOMS. IN ADDITION, BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION THERE WAS DELAY IN TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174685 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387591

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR