BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3881983 · Received June 18, 2014

    Report

    Report Number
    2939301-2014-14787
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 6, 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
    TX, US
    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 ¿ (07/09/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 6/24/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/26/2014 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT DOES NOT RECALL WHEN THE ALLEGED INACCURACY BEGAN. AT AN UNSPECIFIED DATE/TIME, THE PATIENT OBTAINED BLOOD GLUCOSE READING OF ¿UNKNOWN HI¿ WITH THE SUBJECT METER. THE PATIENT DID NOT PROVIDE THE ACTUAL READINGS OBTAINED WITH THE SUBJECT METER OR OTHER DEVICE. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN, 1000 MG; ¿OGLICIA¿, 5 MG; GLIPIZIDE, 5 MG) AND STATED SHE CONTINUED WITH HER USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿JITTERY AND SWEATY¿. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359257 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3608576

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening