BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2217081 · Received April 14, 2011

    Report

    Report Number
    3005345832-2011-00001
    Event Type
    Other
    Date Received
    April 14, 2011
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIMILAR EMPTY SOLVENT VIAL INCIDENT WAS REPORTED IN (B)(6) 2010, PROMPTING AN FDA INSPECTION. LOCAL FDA OFFICERS VISITED AMNISURE (B)(4) AND CONDUCTED A FULL QUALITY SYSTEM AUDIT FROM (B)(6) 2010. DURING THIS AUDIT, THEY EVALUATED THE CORRECTIVE ACTION OPENED TO INVESTIGATE AND RESOLVE THE RECENT INCREASE IN EMPTY SOLVENT VIAL COMPLAINTS. IT WAS BROUGHT TO THE OFFICER'S ATTENTION THAT WHILE AN EMPTY SOLVENT VIAL MAY RENDER THE DISPOSABLE DIAGNOSTIC TEST KIT UNUSABLE, THIS DOES NOT AFFECT PATIENT SAFETY OR THE CLINICAL DIAGNOSIS. CORRECTIVE ACTIONS TO SOLVE THE PROBLEM WERE DISCUSSED AND FDA OFFICERS AGREED THAT AMNISURE WAS FOLLOWING THROUGH WITH THESE ACTIONS PROPERLY. MR (B)(6) CONTACTED AMNISURE ABOUT AN EMPTY SOLVENT VIAL ON (B)(6) 2011. HIS DESCRIPTION OF THE INCIDENT IS ACCURATE. MR (B)(6) WAS OFFERED A REPLACEMENT SET OF TESTS 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. AMNISURE DID NOT SUBMIT A 3500A FORM BECAUSE THE "MDR FOR MANUFACTURERS" 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, 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.

    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