BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3191948 · Received June 27, 2013

    Report

    Report Number
    3008382007-2013-18564
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 14, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (07/08/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/27/2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND; THE 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

    THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED BUT NOT YET EVALUATED BY LIFESCAN PRODUCT ANALYSIS. THE CONTROL SOLUTION WAS ALSO RETURNED; HOWEVER, TESTING WAS NOT PERFORMED SINCE THE ALLEGED ISSUE PERTAINS TO A METER AND TEST STRIP ISSUE ONLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN A FEW WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF ¿170 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN. BASED ON THE ALLEGED RESULT, THE PATIENT ADMINISTERED HER USUAL DOSE OF INSULIN (34 UNITS). AN HOUR LATER, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SHAKY, DIZZY AND NERVOUS. TREATMENT WAS NOT SPECIFIED. THE PATIENT DENIED TESTING WITH ANOTHER METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. QUALITY CONTROL TESTING WAS PERFORMED WHICH TESTED WITHIN SPECIFICATIONS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJRY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292959 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3441648

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening