BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3132470 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13355
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT REPORTED HAVING SYMPTOMS PRIOR TO THE START OF THE ALLEGED ISSUE THEREFORE THE METER COULD NOT HAVE CAUSED THE ALLEGED INJURY. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN USA, ALLEGING A ONETOUCH VERIOIQ METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT REPORTED AT AN UNKNOWN PRIOR TO THE START OF THE ALLEGED ISSUE ON (B)(6) 2013 HE HAD SYMPTOMS OF "BLURRED VISION, HEADACHE AND DISORIENTED." THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 BETWEEN 2:25 - 2:28PM. THE PATIENT REPORTED HE TAKES INSULIN TO MANAGE HIS DIABETES, 3 OR MORE SHOTS PER DAY AND NORMALLY TESTS 4 OR MORE TIMES A DAY. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT DENIED RECEIVING ANY TREATMENT DUE TO THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING RULED OUT AS AN ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSIONS: THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT REPORTED HAVING SYMPTOMS PRIOR TO THE START OF THE ALLEGED ISSUE THEREFORE THE METER COULD NOT HAVE CAUSED THE ALLEGED INJURY. IN ADDITION, THERE WAS NO EVIDENCE THAT THE LFS PRODUCT(S) WERE WORKING IMPROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237330 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3225282

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening