BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAL TIME HIV-1 CONTROL KIT

    MDR report key: 2708657 · Received February 2, 2012

    Report

    Report Number
    3005248192-2012-00006
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT REAL TIME (B)(6) CONTROL (LIST NO. (B)(4)) IS DESCRIBED IN THE ABBOTT REALTIME (B)(6) PACKAGE INSERT ((B)(4)) AS FOLLOWS: ABBOTT REALTIME (B)(6) CONTROL (LIST NO. (B)(4)): NONINFECTIOUS ARMOURED RNA WITH (B)(6) SEQUENCES IN (B)(6) HUMAN PLASMA. (B)(6) HUMAN PLASMA TESTED AND FOUND TO BE (B)(6) FOR (B)(6). (B)(4). THE ABBOTT REALTIME (B)(6) PACKAGE INSERT ((B)(4)) INSTRUCT USERS TO TAKE NECESSARY PRECAUTIONS AS INDICATED IN THE FOLLOWING TEXT FROM THE LABELING: 'CAUTION: THIS PRODUCT CONTAINS HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. FOR A SPECIFIC LISTING, REFER TO THE REAGENTS SECTION OF THIS PACKAGE INSERT. HUMAN SOURCED MATERIAL HAS BEEN TESTED AND FOUND TO BE (B)(6) TO (B)(6). NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN SOURCES OR INACTIVATED MICROORGANISMS WILL NOT TRANSMIT INFECTION. THEREFORE, ALL HUMAN SOURCED MATERIALS SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS. IT IS RECOMMENDED THAT THESE REAGENTS AND HUMAN SPECIMENS BE HANDLED IN ACCORDANCE WITH THE OSHA STANDARD ON BLOODBORNE PATHOGENS. BIOSAFETY LEVEL 2 OR OTHER APPROPRIATE BIOSAFETY PRACTICES SHOULD BE USED FOR MATERIALS THAT CONTAIN OR ARE SUSPECTED OF CONTAINING INFECTIOUS AGENTS. THESE PRECAUTIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: WEAR GLOVES WHEN HANDLING SPECIMENS OR REAGENTS. DO NOT PIPETTE BY MOUTH. DO NOT EAT, DRINK, SMOKE, APPLY COSMETICS, OR HANDLE CONTACT LENSES IN AREAS WHERE THESE MATERIALS ARE HANDLED. CLEAN AND DISINFECT SPILLS OF SPECIMENS BY INCLUDING THE USE OF A TUBERCULOCIDAL DISINFECTANT SUCH AS 1.0% SODIUM HYPOCHLORITE OR OTHER SUITABLE DISINFECTANT. DECONTAMINATE AND DISPOSE OF ALL POTENTIALLY INFECTIOUS MATERIALS IN ACCORDANCE WITH LOCAL STATE, AND FEDERAL REGULATIONS. ABBOTT REALTIME (B)(6) CALIBRATOR KIT, CONTROL KIT, INTERNAL CONTROL, (B)(6) OLIGONUCLEOTIDE REAGENT, AND ACTIVATION REAGENT CONTAIN A MIXTURE OF 5-CHLORO-2-METHYL-4-ISOTHIAZOLIN-3-ONE AND 2-METHYL-4-ISOTHIAZOLIN-3-ONE WHICH ARE COMPONENTS OF PROCLIN. THE COMPONENTS ARE CLASSIFIED PER APPLICABLE EUROPEAN COMMUNITY (EC) DIRECTIVES AS IRRITANT (XI)."

    Description of Event or Problem · 1

    THE ABBOTT REAL TIME (B)(6) IS AN IN VITRO REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF (B)(6) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM (B)(6) INDIVIDUALS OVER THE RANGE OF (B)(6). THE ABBOTT REAL TIME (B)(6) ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LAB MARKERS FOR DISEASE PROGNOSIS AND FOR USE AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AN MEASURED BY CHANGES IN (B)(6) LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR (B)(6) OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF (B)(6) INFECTION. A CUSTOMER AT (B)(6) REPORTED THAT THE CONTENTS OF A REAL TIME (B)(6) HIGH (B)(6) CONTROL VIAL HAD SPILLED ON A SMALL OPEN WOUND ON A TECHNICIAN'S LEG WHILE THE TECH WAS CLEARING REAGENTS FROM THE REAL TIME M2000SP. THE TECH NOTICED THE SPILL ON HER CUT AFTER SHE ARRIVED HOME APPROX 5 HOURS LATER. THE TECH IS RECEIVING STANDARD ANTIRETROVIRAL THERAPY AND WILL UNDERGO F/U TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAL TIME HIV-1 CONTROL KIT NONE MZF ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1