BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESIGN STAPH LATEX

    MDR report key: 1588044 · Received January 15, 2010

    Report

    Report Number
    1215667-2010-00002
    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

    IN RESPONSE TO THE RECEIPT OF ONE COMPLAINT FOR THIS KIT LOT, AND FOR TWO OTHER KIT LOTS NOTED IN MRN 1215667-2010-00001, WE CONDUCTED AN INVESTIGATION. WE REPEATED QUALITY CONTROL RELEASE TESTING ON RETENTION KITS. OUR TESTING INDICATED REDUCED REACTIVITY (OUT OF SPEC) 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 THIS LOT OF PRODUCT WHICH WAS 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. THE BULK LOT OF STAPH LATEX REAGENT USED TO MANUFACTURE THIS KIT LOT WAS ALSO USED FOR ANOTHER DEVICE. PLEASE REFER TO MFR REPORT NUMBER 1215667-2010-00001. 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). EVAL SUMMARY: NERL RETENTION SAMPLE KIT WAS TESTED ACCORDING TO QC RELEASE TESTING PROCEDURE. DURING THE COMPLAINT INVESTIGATION FOR LIFESIGN STAPH LATEX LOT # 1009029, THE FOLLOWING RESULTS WERE OBTAINED.

    Description of Event or Problem · 1

    ON DECEMBER 15, 2009, IT WAS CONFIRMED THAT THE STAPH LATEX REAGENT WAS NOT SUFFICIENTLY REACTIVE WITH A KNOWN 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 KIT IN QUESTION WAS TESTED WITH THE POSITIVE CONTROL WEAKENED AGGLUTINATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESIGN STAPH LATEX JWX NERL DIAGNOSTICS LLC. 1009029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other