BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAMPOLE LABORATORIES STAPH LATEX KIT

    MDR report key: 1588030 · Received January 15, 2010

    Report

    Report Number
    1215667-2010-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 15, 2010
    Manufacturer
    NERL DIAGNOSTICS, LLC
    Product Code
    JWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 1110049. IN RESPONSE TO THE RECEIPT OF THESE COMPLAINTS, WE CONDUCTED AN INVESTIGATION. BOTH OF THESE LOTS WERE MANUFACTURED FROM THE SAME BULK LOT OF STAPH LATEX REAGENT. WE REPEATED QUALITY CONTROL RELEASE TESTING ON RETENTION KITS AS WELL AS RETURNED KITS. OUR TESTING INDICATED REDUCED REACTIVITY (OUT OF SPECIFICATION) OF THE LATEX REAGENT IN THE PRESENCE OF THE RECOMMENDED POSITIVE CONTROL. BASED ON THESE RESULTS, WE CONDUCTED A RISK ASSESSMENT. A DECISION WAS MADE TO RECALL BOTH LOTS OF PRODUCT WHICH WERE SHIPPED TO ONE DISTRIBUTOR. WE ARE WORKING WITH THAT DISTRIBUTOR TO ENSURE THAT ALL END USERS ARE NOTIFIED OF THE RECALL. A SAMPLE LETTER TO THE DISTRIBUTOR IS ATTACHED. IN ADDITION, TO ENSURE THAT THIS PRODUCT MALFUNCTION DOES NOT RECUR, THE FOLLOWING MEASURES WERE TAKEN. THE SOP FOR STOCK CULTURE MAINTENANCE (B)(4) HAS BEEN UPDATED TO INCLUDE THE ORGANISMS UTILIZED FOR THE QC BULK AND RELEASE TESTING FOR THE STAPH LATEX KIT. APPROPRIATE QC PERSONNEL HAVE BEEN TRAINED TO THE NEW REVISION (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, IT WAS CONFIRMED THAT THE STAPH LATEX REAGENT WAS NOT SUFFICIENTLY REACTIVE WITH THE RECOMMENDED POSITIVE CONTROL. THE STAPH LATEX KIT IS A LATEX AGGLUTINATION KIT IN WHICH THE REAGENT SHOULD AGGLUTINATE WHEN TESTED WITH A KNOWN POSITIVE CONTROL ORGANISM (B)(6). WHEN THE KITS IN QUESTION WERE TESTED WITH THE POSITIVE CONTROL, AS RECOMMENDED IN THE PACKAGE INSERT, WEAKENED AGGLUTINATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAMPOLE LABORATORIES STAPH LATEX KIT JWX NERL DIAGNOSTICS, LLC 0919119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other