BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO 2 METER

    MDR report key: 9664301 · Received February 4, 2020

    Report

    Report Number
    3008382007-2020-03860
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 3, 2020
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT METER WAS RETURNED TO LIFESCAN FOR ANALYSIS. THE METER PASSED PERFORMANCE TESTING AND THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WHICH DID NOT IDENTIFY ANYTHING DURING THE MANUFACTURING PROCESS THAT WOULD IMPACT PRODUCT SAFETY OR PERFORMANCE.

    Description of Event or Problem · 1

    ON FEBRUARY 3, 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) FRANCE, ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE AFTERNOON OF (B)(6) 2020. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH RESULTS OF ¿226, 246, 222, 158, 247, 321, 217 AND 260 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN (3 INJECTIONS OF HUMALOG DAILY AND 10 UNITS OF LANTUS) ON A SELF-ADJUSTING DOSE. IN RESPONSE TO THE ELEVATED RESULTS, THE PATIENT CLAIMED HE INCREASED HIS DOSE OF INSULIN TO 16 UNITS ON (B)(6) 2020. THE PATIENT REPORTED THAT ON THE MORNING OF (B)(6) 2020, HE BEGAN TO FEEL ¿BAD¿ AND HAD ¿CRISIS OF HYPOGLYCEMIA.¿ THE PATIENT CLAIMED HE WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH FOOD AND DRINK AND THAT HIS BLOOD GLUCOSE WAS MEASURED AT ¿39 MG/DL¿ ON THE EMS DEVICE PRIOR TO TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. THE PATIENT DECLINED TO HAVE REPLACEMENT PRODUCTS SENT TO HIM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128320 OT VERIO 2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4566406

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R