BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TACROLIMUS WHOLE BLOOD PRECIPITATION REAGENT

    MDR report key: 2341270 · Received November 17, 2011

    Report

    Report Number
    1415939-2011-00691
    Event Type
    Injury
    Date Received
    November 17, 2011
    Date of Event
    May 27, 2011
    Report Date
    October 31, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MLM
    PMA / PMN Number
    K070820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIVER DYSFUNCTION. DEVICE HANDLING ISSUE. IN ORDER TO ISOLATE THE POSSIBLE ASSAYS, WE REVIEWED ALL ARCHITECT ASSAYS THAT ARE UTILIZED AT THE CUSTOMER'S FACILITY AND DETERMINED THAT ARCHITECT CYCLOSPORINE WHOLE BLOOD PRECIPITATION REAGENT, LIST 1L75-55, ARCHITECT SIROLIMUS WHOLE BLOOD PRECIPITATION REAGENT, LIST 1L76-55 AND ARCHITECT TACROLIMUS WHOLE BLOOD PRECIPITATION REAGENT, LIST 1L77-55 ALL HAVE THE POSSIBILITY OF AFFECTING THE LIVER. CUSTOMER COMPLAINTS FOR THE THREE ASSAYS RECEIVED TO-DATE WERE REVIEWED TO DETERMINE IF OTHERS HAVE EXPERIENCED THE SAME ISSUE. OUR REVIEW OF THIS DATA DID NOT IDENTIFY ANY PROBLEMATIC COMPLAINT ACTIVITY THAT WOULD INDICATE THIS PRODUCT IS PERFORMING CONTRARY TO ITS CLAIMS. ADDITIONALLY, THE PACKAGE INSERTS AND MATERIAL SAFETY DATA SHEETS FOR THE THREE ASSAYS WERE REVIEWED. THIS REVIEW DID INDICATE THAT THE ASSAYS DO HAVE THE POTENTIAL TO AFFECT THE LIVER. HOWEVER, SAFETY PRECAUTIONS/INSTRUCTIONS ARE PROVIDED TO MINIMIZE THE RISK. THE CUSTOMER WAS REFERRED TO THE PRECAUTIONS SECTION OF EACH ASSAYS PACKAGE INSERT. BASED ON THIS INVESTIGATION, WE HAVE CONCLUDED THAT THE ARCHITECT CYCLOSPORINE WHOLE BLOOD PRECIPITATION REAGENT, ARCHITECT SIROLIMUS WHOLE BLOOD PRECIPITATION REAGENT AND ARCHITECT TACROLIMUS WHOLE BLOOD PRECIPITATION REAGENT ARE PERFORMING AS INTENDED AND MEETING THEIR SAFETY, EFFECTIVENESS AND LABEL CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER HAD BLOODWORK PERFORMED FOR AN UNSPECIFIED REASON AND DISCOVERED THAT LIVER PARAMETERS WERE ELEVATED. THE CUSTOMER CONTACTED ABBOTT TO INQUIRE WHETHER A SPLASH TO THE ARM DURING DISPOSAL OF AN UNKNOWN ARCHITECT REAGENT APPROXIMATELY ONE MONTH PRIOR COULD HAVE CAUSED AN INCREASE IN LIVER TEST RESULTS. THE CUSTOMER REPORTED THAT THEIR SKIN WAS INTACT BUT NO INFORMATION WAS PROVIDED REGARDING WHICH REAGENT, VOLUME OF REAGENT IN CONTACT WITH SKIN, LENGTH OF EXPOSURE TIME, FIRST AID MEASURES TAKEN TO ADDRESS THE SKIN EXPOSURE, NOR WHETHER THERE WAS ANY SKIN IRRITATION OR ALLERGIC RESPONSE. THE CUSTOMER PROVIDED NO INFORMATION REGARDING ANY MEDICAL TREATMENT OR DIAGNOSTIC TESTING OTHER THAN RESULTS OF BLOOD TESTS. THERE WAS NO LIVER FUNCTION TESTING PRIOR TO THE EVENT FOR COMPARISON. THE BLOODWORK RESULTS FOR THE PATIENT WERE REVIEWED BY THE ABBOTT. THE PATIENT RESULTS INDICATE THAT THE CUSTOMER HAS ELEVATED LIVER ENZYMES BUT THE TESTS WERE NEGATIVE FOR HEPATITIS A, B AND C. ABBOTT REVIEWED THE LIST OF REAGENTS SUPPLIED TO THIS CUSTOMER AND THE ASSOCIATED MATERIAL SAFETY DATA SHEETS.. A FEW OF THE REAGENTS SHIPPED TO THIS CUSTOMER WERE IDENTIFIED AS BEING POTENTIALLY TOXIC IF THEY CAME INTO CONTACT WITH SKIN. THESE REAGENTS DO HAVE THE POTENTIAL TO IMPACT THE LIVER AND A PRE-EXISTING LIVER CONDITION MAY BE AGGRAVATED BY EXPOSURE. THE REAGENT PACKAGE INSERT FOR THESE REAGENTS CLEARLY STATE TO WEAR SUITABLE PROTECTIVE CLOTHING, GLOVES AND EYE/FACE PROTECTION WHEN HANDLING THESE PRODUCTS. AT THE CURRENT TIME, WITHOUT ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO ASCERTAIN WHETHER THESE REAGENTS WERE THE SUBJECT OF THE EXPOSURE INCIDENT. NO SPECIFIC INFORMATION ABOUT THE TYPE OF TREATMENT THE CUSTOMER RECEIVED WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TACROLIMUS WHOLE BLOOD PRECIPITATION REAGENT MLM ABBOTT LABORATORIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARCHITECT I2000SR ANALYZER LIST # 3M74-01| SERIAL # (B)(4)