BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3974419 · Received August 3, 2014

    Report

    Report Number
    2939301-2014-19347
    Event Type
    Injury
    Date Received
    August 3, 2014
    Report Date
    July 24, 2014
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (08/25/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. DESPITE TWO ATTEMPTS, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) WAS UNABLE TO CONTACT THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON LFS¿ CUSTOMER SERVICE DOCUMENTATION. THE PATIENT REPORTED, ON UNKNOWN DATES AND TIMES, HE OBTAINED INACCURATELY HIGH READINGS ON THE SUBJECT METER COMPARED TO HIS PREVIOUS METER (ONETOUCH ULTRA). THE PATIENT WAS UNABLE TO PROVIDE THE RESULTS OBTAINED ON EITHER OF THE DEVICES. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER) AND ADMINISTERS 4 INJECTIONS OF "INSUMAN" RAPID PER DAY. IT IS NOT KNOWN IF THE PATIENT ADJUSTED HIS INSULIN DOSE BASED ON THE ALLEGED HIGH READINGS HE WAS OBTAINING WITH THE SUBJECT METER. THE PATIENT ALLEGED HE DEVELOPED SYMPTOMS OF ¿TINGLE IN THE LEGS AND SWEATING¿ AND WAS ¿VERY HUNGRY ; HOWEVER, COULD NOT CONFIRM IF THE SYMPTOMS OCCURRED PRIOR TO, OR AFTER, THE METER INACCURACY. IN RESPONSE TO THE SYMPTOMS, THE PATIENT ALLEGED THAT HE TREATED HIMSELF WITH ¿FOOD AND/OR DRINK¿. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA SEEMINGLY AFTER HE BEGAN TESTING WITH THE SUBJECT METER. THE ALLEGED METER ISSUE WITH THE LFS DEVICE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452649 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R