BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3420232 · Received October 21, 2013

    Report

    Report Number
    2939301-2013-05968
    Event Type
    Injury
    Date Received
    October 21, 2013
    Report Date
    October 8, 2013
    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
    NY, 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 ¿ (11/01/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/23/2013 AND 10/25/2013, RESPECTIVELY, 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY COMPARED TO THE SAME METER, AND INACCURATELY HIGH COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE PATIENT WAS NOT AVAILABLE FOR FOLLOW UP QUESTIONS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE OCCURRED 1 MONTH PRIOR TO CONTACTING LFS IN THE MID AFTERNOON. THE PATIENT REPORTED READINGS OF ¿46, 69, 102, 227, 569 MG/DL¿, ¿HI VS 189MG/DL¿, ¿105 VS 405MG/DL¿ AND ¿477 VS 89MG/DL¿ WERE OBTAINED. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% OR <=20MG/DL WHEN OBTAINED WITHIN 20 MINUTES. THE PATIENT STATED SHE BELIEVED THE READINGS OF ¿569, 477 AND 277 MG/DL¿ WERE INACCURATELY HIGH COMPARED TO HER FEELINGS. THE PATIENT REPORTED USING A COMBINATION OF LANTUS AND HUMALOG INSULIN AND REFUSED TO REPORT THE DOSE. THE PATIENT REPORTED IN RESPONSE TO THE ALLEGED ISSUE SHE INCREASED HER USUAL DOSE OF MEDICATION ON AN UNKNOWN DATE AND TIME AND ¿PASSED OUT¿ DUE TO HYPOGLYCEMIA. THE PATIENT REPORTED ON ¿MONDAY OR TUESDAY¿ IN THE MID AFTERNOON SHE WENT TO THE EMERGENCY ROOM AND WAS GIVEN A GLUCAGON INJECTION BY AN HEALTHCARE PROFESSIONAL (HCP). AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT WAS FOUND TO BE USING AN APPROVED SAMPLE SITE AND THE CORRECT TESTING STEPS. THE PATIENT¿S TEST STRIP VIAL WAS IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE LINKAGE BETWEEN THE ALLEGED METER READINGS AND THE ALLEGED INJURY REMAIN UNCLEAR, DESPITE REPEATED ATTEMPTS, THE PATIENT WAS NOT AVAILABLE FOR ADDITIONAL INFORMATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE THE PATIENT REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538217 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3516950

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R