BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3931430 · Received July 14, 2014

    Report

    Report Number
    2939301-2014-17298
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ¿ (09/09/2014). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 8/25/2014 AND 9/3/2014, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/27/2014 AND 9/9/2014, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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) (B)(4) ALLEGING HIS ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED HIS FEELINGS AND OR NORMAL RESULTS AND TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE¿S (CSR) DOCUMENTATION. THE PATIENT DOES NOT RECALL WHEN THE ALLEGED INACCURACY BEGAN. ON (B)(6) 2014 ¿AROUND LUNCH¿ THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿297 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (ACTRAPID, SELF-ADJUSTER) AND STATED HE TOOK HIS USUAL DOSE OF INSULIN (ACTRAPID, 6 UNITS) IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED HE THEN RODE HIS BIKE TO WORK (10 KM) AND ATE A BANANA. THE PATIENT RETESTED HIS BLOOD GLUCOSE, 1 HOUR AFTERWARDS, AND STATED HE OBTAINED A READING OF ¿134 MG/DL¿ WITH THE SUBJECT METER. ON (B)(6) 2014 AT 6:00 P. M. THE PATIENT¿S COLLEAGUE FOUND THE PATIENT ¿UNCONSCIOUS¿. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND AT 6:30 P. M. OBTAINED A READING OF ¿LOW¿ WITH ANOTHER DEVICE (UNKNOWN TYPE). EMS IMMEDIATELY GAVE THE PATIENT ¿IV GLUCOSE¿ AND TRANSPORTED HIM TO THE HOSPITAL. THE PATIENT ARRIVED AT THE HOSPITAL AT 7:00 P. M. AND MENTIONED HE WAS ¿CONSCIOUS¿. THE PATIENT STATED HE WAS ADMITTED TO THE HOSPITAL FOR 1 NIGHT. AT AN UNSPECIFIED TIME ON (B)(6) 2014 THE PATIENT STATED HE OBTAINED A BLOOD GLUCOSE READING OF ¿297 MG/DL¿ WITH THE SUBJECT METER AND ¿149 MG/DL¿ WITH ANOTHER DEVICE (ULTRA EASY), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. THE PATIENT ALSO MENTIONED THAT, AT AN UNSPECIFIED TIME THAT SAME DAY, HE RETESTED HIS BLOOD GLUCOSE AND OBTAINED A READING OF ¿329 MG/DL¿ WITH THE SUBJECT METER AND ¿224 MG/DL¿ WITH ANOTHER DEVICE (ULTRA EASY), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE 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
    409547 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3537816

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R