BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4110368 · Received September 23, 2014

    Report

    Report Number
    2939301-2014-25153
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 9, 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

    FOLLOW-UP # 1 ¿ (11/24/2014). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 11/5/2014 AND 11/21/2014, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/11/2014 AND 11/23/2014, 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. 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

    FOLLOW-UP #2 - (11/24/2014) - 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVES (CSR) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT DOES NOT RECALL WHEN THE ALLEGED INACCURACY BEGAN. AT AN UNSPECIFIED DATE/TIME, THE PATIENT STATED SHE OBTAINED BLOOD GLUCOSE READINGS THAT WERE ¿GREATER THAN 40 MG/DL¿ COMPARED TO ANOTHER DEVICE (ONE TOUCH ULTRA EASY & ONE TOUCH ULTRA 2); HOWEVER, SHE DID NOT PROVIDE THE ACTUAL RESULTS OBTAINED WITH THE SUBJECT METER OR OTHER DEVICES. THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE, SELF-ADJUSTER) AND DENIED TAKING ANY ACTION IN REGARDS TO HER NORMAL DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED INACCURATE HIGH READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿SWEATING, TREMBLING, AND BLURRY VISION¿, BUT COULD NOT CONFIRM IF THE SYMPTOMS DEVELOPED BEFORE OR AFTER THE INACCURACY STARTED. THE PATIENT STATED SHE SELF-TREATED WITH FOOD AND OR DRINK IN RESPONSE TO THE SYMPTOMS. 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 REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592263 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3620647

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R