BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO FLEX METER

    MDR report key: 12215309 · Received July 22, 2021

    Report

    Report Number
    3008382007-2021-04193
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 22, 2021
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885010986
    PMA / PMN Number
    K150214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS SUPPLEMENTAL IS BEING SENT TO INCLUDE THE INVESTIGATION CONCLUSION CODE THAT WAS OMITTED FROM THE H6 FIELD OF THE INITIAL REPORT. THE INVESTIGATION CONCLUSION CODE THAT SHOULD HAVE BEEN INCLUDED AT THE TIME OF SUBMISSION OF THE INITIAL REPORT IS: 67. 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) 2021, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER CUSTOMER CARE (CC) REVIEWED THE CALL. THE PATIENT ALLEGED THAT THE SUBJECT METER STARTED DISPLAYING INACCURATE HIGH READINGS ON (B)(6) 2021, AT 7 AM. THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿190, 194, 110 AND 91 MG/DL¿ ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT USUALLY MANAGES HIS DIABETES WITH PILLS (METFORMIN ¿ DOSE UNSPECIFIED) AND INSULIN (HUMULIN R ¿ 5 UNITS) AND HE DENIED MAKING ANY CHANGE TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. IMMEDIATELY AFTER THE PATIENT OBTAINED THE READINGS IN THE MORNING, HE STATED THAT HE FELT HIS ¿DIABETES WENT ALL THE WAY DOWN¿ AND HE FELT ¿SHAKY¿. THE PATIENT CLAIMED THAT HE TOOK ¿SOMETHING SWEET¿. NO OTHER BLOOD GLUCOSE READINGS HAVE BEEN REPORTED. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THAT THE PATIENT DID NOT HAVE A CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS 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 THE ALLEGED PRODUCT ISSUE BEGAN. THERE IS INSUFFICIENT INFORMATION TO RULE OUT THE CONTRIBUTION OF THE SUBJECT METER TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107857 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 023-271 4721680 00353885010986

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening