BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4505681 · Received February 11, 2015

    Report

    Report Number
    2939301-2015-05360
    Event Type
    Injury
    Date Received
    February 11, 2015
    Report Date
    February 5, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER FOR THE PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE REPRESENTATIVE (CCR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN CCR MADE A FOLLOW UP CALL WITH THE PATIENT. THE CCR WAS ADVISED BY THE REPORTER THAT ALLEGED INACCURACY BEGAN ON THE ¿27 OR (B)(6) 2015¿. THE REPORTER STATED THE PATIENT OBTAINED INACCURATE BLOOD GLUCOSE RESULTS OF ¿125, 142, 144, 217 AND 154MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿83, 109, 150, 150 AND 109MG/DL¿ ON ANOTHER METER (ULTRA) AND ¿88, 110MGDL/L¿ ON A ONETOUCH VITA METER, RESPECTIVELY. THE RESULTS WERE OBTAINED LESS THAN 30 MINUTES APART. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER). THE REPORTER FOR THE PATIENT INDICATED THAT THE PATIENT INCREASED HIS DOSE OF INSULIN BY 3 UNITS AS A RESULT OF THE ALLEGED INACCURACY. THE REPORTER FOR THE PATIENT STATED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGED PRODUCT ISSUE BEGAN HE DEVELOPED SYMPTOMS OF ¿SHAKING, HE FELT IT COMING¿. THE PATIENT SELF-TREATED WITH FOOD AND/OR DRINK. AT THE TIME OF TROUBLE SHOOTING, THE CCR CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE CORRECT APPROVED SAMPLE SITE WAS USED. CCR ALSO NOTED THAT PATIENT USED THE INCORRECT TESTING PROCEDURE; THE PATIENT USES THE SAME SAMPLE FOR THE COMPARISON OBTAINED ON THE METERS. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103302 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3717488

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening