BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2250919 · Received September 12, 2011

    Report

    Report Number
    3005345832-2011-00003
    Event Type
    Other
    Date Received
    September 12, 2011
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), POINT OF CARE COORDINATOR CONTACTED AMNISURE REGARDING EMPTY SOLVENT VIALS ENCOUNTERED IN LOT A1001 ON (B)(6) 2011. (B)(6) WAS OFFERED REPLACEMENTS FOR THE INCONVENIENCE AND WAS INFORMED OF THE MANUFACTURING CHANGES BEING PUT INTO EFFECT. THESE CHANGES INCLUDE, BUT ARE NOT LIMITED TO, THE ADOPTION OF AN AUTOMATED VIAL FILLING AND CAPPING PROCESS THAT EMPLOYS A VERY SPECIFIC TORQUE, NEW CAPS AND VIALS THAT ALLOW FOR A TIGHTER CLOSURE, AND INCREASED FILLED-VIAL INSPECTION PARAMETERS. LISA MERRILL'S DESCRIPTION OF THE INCIDENT IN UF REPORT #(B)(4) IS MOSTLY ACCURATE. HOWEVER, THE MANUFACTURING ISSUE CITED COULD NOT RESULT IN ADVERSE EVENTS. THUS, AMNISURE DID NOT SUBMIT A 3500A FORM BECAUSE THE "MDR FOR MANUFACTURES" GUIDANCE DOCUMENT STATES THAT A REPORT SHOULD ONLY BE FILED IN THE EVENT OF A MALFUNCTION THAT MAY CAUSE AN ADVERSE EVENT OR SERIOUS INJURY. AS PREVIOUSLY DESCRIBED IN MEDWATCH MANUFACTURING REPORT # 3005345832-2011-00001, THIS PRODUCT DEFECT RENDERS THE DIAGNOSTIC TEST KIT UNUSABLE, BUT DOES NOT HAVE THE POTENTIAL TO HARM THE PATIENT OR PROVIDE AN INACCURATE CLINICAL DIAGNOSIS. ON (B)(6) 2011, WE CONTACTED (B)(6) TO FOLLOW UP AND ENSURE ALL WAS WELL. SHE WAS HAPPY WITH OUR RESPONSE TO THEIR COMPLAINT AND THE REPLACEMENTS PROVIDED. THEY WILL BE SOON MOVING TO A NEW LOT OF TESTS WHICH WAS PRODUCED UNDER THE CORRECTIVE ACTIONS MANUFACTURED WITH NEW VIALS PRODUCED WITH AN AUTOMATED PROCESS AND KNOWN TORQUE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NQM

    Patients

    Seq Age Sex Outcome Treatment
    1