BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO REFLECT METER

    MDR report key: 12866261 · Received November 23, 2021

    Report

    Report Number
    3008382007-2021-04277
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 22, 2021
    Report Date
    November 23, 2021
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K193475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED FOR THE TEST STRIP LOT. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE LOT DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. IN ADDITION, SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED INCLUDING THE REPORTED METER. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE METER DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO REFLECT METER DISPLAYED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT DID NOT REPORT WHEN THE SUBJECT METER STARTED READING ALLEGEDLY ERRATIC. THE PATIENT INFORMED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF ¿410, 143, 153, 163 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER) AND DENIED THAT HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMS THAT HE DOES NOT KNOW HOW MUCH INSULIN TO TAKE BECAUSE OF THE HIGH DIFFERENCE BETWEEN THE READINGS. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED THE SYMPTOM OF ¿CLOUDY VISION¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT FOR THE REPORTED SYMPTOM. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA ESTABLISHED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. 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. THERE IS EVIDENCE OF DELAY IN TREATMENT AS THE PATIENT CLAIMS THAT HE DID NOT KNOW HOW MUCH INSULIN TO TAKE BASED ON THE READINGS FROM THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763496 OT VERIO REFLECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4756031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening