BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3110567 · Received May 14, 2013

    Report

    Report Number
    3008382007-2013-11409
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/23/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/3/2013 AND 7/18/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (B)(4), ALLEGING SHE WAS DEVELOPING SYMPTOMS OF "HEADACHE AND DIZZY" WHEN SHE "INSERTED TEST STRIP INTO THE METER AND APPLIED BLOOD". THE PATIENT REPORTED THE ALLEGED ISSUE OCCURRED WITHIN 2-3 DAYS OF FIRST USING THE METER. THE CUSTOMER CARE ADVOCATE (CCA) DETERMINED THE CAUSE OF THE ALLEGED SYMPTOMS WAS UNKNOWN. THE PATIENT REPORTED SHE BELIEVED HER BLOOD GLUCOSE READINGS WERE ACCURATE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSE OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DID NOT REPORTED OBTAINING ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LFS' CRITERIA FOR A SERIOUS INJURY. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213225 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3357159

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR