BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4234021 · Received November 7, 2014

    Report

    Report Number
    2939301-2014-29871
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/26/2015 DEVICE EVALUATION.THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 12/5/2014 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/23/2014 WITH THE FOLLOWING FINDINGS:ERROR 2, 3 AND 4 MESSAGES OBSERVED IN THE ERROR LOG, BUT THE ERROR WAS NOT REPRODUCED DURING THE INVESTIGATION. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAD NO TESTING PERFORMED, AS THE PATIENT RETURNED AN EMPTY VIAL OF TEST STRIPS. 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

    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 PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA2 METER HAD DISPLAYED AN UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW UP CALL FROM THE MEDICAL SURVEILLANCE SPECIALIST (MSS). THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE FIRST OCCURRED ON 09/29/2014 AT NOON. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). ON ¿09/29/2014 - 10/29/2014, 3 TIMES A DAY¿ THE PATIENT REPORTED INCREASING HER MEDICATIONS ¿APIDRA ¿ UNKNOWN DOSE AMOUNT¿ AS A RESULT OF THE ALLEGED ERROR MESSAGE APPEARING. SHE ALLEGED, 24 HOURS AFTER THE ISSUE BEGAN THAT SHE DEVELOPED SYMPTOMS OF ¿HIGHER GLUCOSE READING, DUE TO STRESS¿. SHE COULD NOT RECALL THE ACTUAL METER READINGS. THE MSS NOTED THAT THE PATIENT STATED FEELING ¿DIZZY¿. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THERE WAS A STRIP FILL PROBLEM WITH NEW STRIPS. DURING A WALK THROUGH RETEST THE ISSUE WAS RESOLVED. HOWEVER THE PATIENT ALSO STATED THAT THE ALLEGED ISSUE WAS ¿FREQUENT AND RECURRING¿. THE CCA NOTED THAT THE ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED METER/PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716576 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3673900

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR