BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 7410520 · Received April 10, 2018

    Report

    Report Number
    3008382007-2018-01065
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    April 2, 2018
    Report Date
    April 4, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008402
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE 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. ANALYSIS WAS NOT POSSIBLE FOR THE RETURNED TEST STRIPS DUE TO UNKNOWN STORAGE AND HANDLING PREVENTING THE ALLEGATION BEING PHYSICALLY INVESTIGATED. 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 PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH PING METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2018, 6:00AM. HE STATED THAT HE OBTAINED ALLEGED BLOOD GLUCOSE RESULTS OF ¿323, 188, 353, 154, 143, 157, 199 AND 183MG/DL¿ ON THE SUBJECT METER, PERFORMED LESS THAN 20 MINUTES APART. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LFS¿ CRITERIA FOR PRECISION. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER) AND METFORMIN. HE REPORTED THAT HE MADE NO CHANGE TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. APPROXIMATELY 1 DAY AFTER THE ALLEGED PRODUCT ISSUE BEGAN THE PATIENT HAD DEVELOPED SYMPTOMS OF ¿SWEATY, BLURRY VISION AND CANNOT WALK STRAIGHT¿. THE PATIENT STATED THAT ON (B)(6) 2018, 5:15AM, HE SELF- TREATED WITH GLUCOSE TABS/GEL. THE PATIENT DENIED USING ANOTHER DEVICE TO OBTAIN A BLOOD GLUCOSE RESULT. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLE WAS TAKEN FROM AN APPROVED SAMPLE SITE AND THE CORRECT TESTING STEPS WERE USED. THE CCA CONFIRMED THAT THE TEST STRIP VIAL WAS NEITHER CRACKED NOR BROKEN. THE TEST STRIPS WERE STORED CORRECTLY AND WITHIN EXPIRY DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A TEST. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258516 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4218306 00353885008402

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R