BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 8114286 · Received November 29, 2018

    Report

    Report Number
    3008382007-2018-03280
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 11, 2018
    Report Date
    November 15, 2018
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885008730
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. LIFESCAN ALSO CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO2 METER PRODUCED AN INACCURATELY HIGH BLOOD GLUCOSE READING IN COMPARISON TO HER FEELINGS/NORMAL RESULTS, AND THAT SHE PERFORMED A CONTROL SOLUTION TEST ON THE SUBJECT METER AND THE RESULT FELL OUTSIDE THE EXPECTED CONTROL SOLUTION RANGE. THIS COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ADVISED THE CSR THAT SHE STARTED TO OBTAIN ALLEGED INACCURATELY HIGH RESULTS ON (B)(6) 2018 AROUND 9.00AM. SHE STATED THAT ON (B)(6) 2018 AROUND 9.00AM, SHE OBTAINED AN ALLEGED INACCURATELY HIGH READING OF ¿235 MG/DL¿ ON THE SUBJECT METER, COMPARED TO HER FEELINGS/NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT EXPLAINED THAT IMMEDIATELY AFTER SHE OBTAINED THE ALLEGED INACCURATELY HIGH READING, SHE PERFORMED A CONTROL SOLUTION TEST ON THE SUBJECT METER AND OBTAINED A RESULT OF ¿200 MG/DL¿, WHICH FELL OUTSIDE THE SPECIFIED RANGE (102-138 MG/DL) ON THE TEST STRIP VIAL. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (GLIMEPIRIDE; 4MG PER DAY) AND EXPLAINED THAT SHE FOLLOWED HER NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT SHE DEVELOPED SYMPTOMS OF ¿SHAKING AND EYES ARE BLURRING¿ AFTER THE ALLEGED PRODUCT ISSUE BEGAN BUT DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THE CSR ALSO NOTED THAT THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. IT WAS CONFIRMED THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE WITHIN EXPIRY DATE, AND THAT THE CORRECT TESTING STEPS WERE BEING FOLLOWED. THE CSR WAS UNABLE TO WALK THE PATIENT THROUGH A CONTROL SOLUTION TEST DURING TROUBLESHOOTING BECAUSE THE PATIENT HAD DISCARDED THEIR CONTROL SOLUTION. REPLACEMENT PRODUCTS, INCLUDING CONTROL SOLUTION, HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING AN INACCURATE BLOOD GLUCOSE READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956276 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4392447 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening