BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3070833 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08553
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 11, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (07/23/2013). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/16/2013 AND 7/18/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE TEST STRIPS 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.ADDITIONAL INFORMATION:THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING.

    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

    (B)(4): THE METER PASSED TESTING, NO FAULTS WERE FOUND, AND THE METER FUNCTIONED PROPERLY; PA WAS UNABLE TO REPRODUCE THE COMPLAINT. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THERE WERE MORE TEST STRIPS OBSERVED N THE VIAL THAN EXPECTED. 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)(4) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT A COUPLE OF DAYS PRIOR TO CONTACTING LFS HE TESTED WITH THE SUBJECT METER RIGHT AFTER EXERCISING AND OBTAINED A READING OF "5.4 MMOL/L (97 MG/DL)". THE PATIENT INFORMED THE CSR THAT HE INITIALLY DID NOT FEEL THE READING WAS INCORRECT; HOWEVER, 2-3 MINUTES AFTER TESTING HE BEGAN TO FEEL SHAKY. AT THE ONSET OF THE SYMPTOM, THE PATIENT STATED HE TESTED HIS BLOOD GLUCOSE WITH HIS OTHER METER (FREESTYLE) AND OBTAINED A RESULT OF "4.2 MMOL/L (76 MG/DL)". BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30 MG/DL. IN RESPONSE TO THE SYMPTOM AND/OR READING OBTAINED ON THE OTHER DEVICE, THE PATIENT REPORTED THAT HE TREATED SELF WITH TWO GLUCOSE TABLETS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE TEST STRIPS HE USED WERE IN GOOD CONDITION. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER OBTAINING AN ALLEGED INACCURATE RESULT WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173129 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3349832

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R