BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 8412663 · Received March 12, 2019

    Report

    Report Number
    3002809144-2019-00063
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    December 1, 2017
    Report Date
    March 12, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3002809144-02/27/19-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICES: ALINITY I PROCESSING MODULE, 03R65-01, (B)(4). ALINITY C PROCESSING MODULE, 03R67-01, (B)(4). CORRECTION/REMOVAL NUMBER: 3002809144-02/27/19-001-C. A PRODUCT CORRECTION LETTER WAS ISSUED ON FEBRUARY 26, 2019 TO ALL ALINITY CI-SERIES PROCESSING MODULE CUSTOMERS. THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING THE SAFETY INTERLOCK COVERING THE SEPTUM PIERCING PROBES WITHIN THE BULK SOLUTION BOTTLE HOLDER, WHICH MAY NOT DEPLOY WHEN A BULK SOLUTION BOTTLE IS REMOVED FROM EITHER THE ALINITY I PROCESSING MODULE OR THE ALINITY C PROCESSING MODULE. THE LETTER FURTHER WARNS THE CUSTOMER OF THE PROBE STICK HAZARD AND POTENTIAL EXPOSURE OF UNPROTECTED SKIN TO THE BULK SOLUTIONS. THE ALINITY I TRIGGER SOLUTION CONTAINS HYDROXIDE AT A CONCENTRATION THAT MAY CAUSE SKIN IRRITATION; THE ALINITY I CONCENTRATED WASH BUFFER CONTAINS 5-BROMO-5-NITRO-1,3-DIOXANE, WHICH MAY PRODUCE AN ALLERGIC REACTION; AND THE ALINITY C ALKALINE WASH CONTAINS SODIUM HYDROXIDE AT A CONCENTRATION THAT MAY CAUSE SEVERE SKIN BURNS. THE PRODUCT CORRECTION LETTER PROVIDES INSTRUCTIONS TO CONTINUE TO FOLLOW THE ALINITY CI-SERIES OPERATIONS MANUAL WHEN REPLACING THE BULK SOLUTIONS. AN ABBOTT REPRESENTATIVE WILL CONTACT ALL IMPACTED CUSTOMERS TO SCHEDULE TIME FOR PLACEMENT OF HAZARD LABELING IN THE BULK SOLUTION AREA TO INCREASE AWARENESS OF THIS HAZARD. ADDITIONALLY, THE CI-SERIES OPERATIONS MANUAL IS BEING UPDATED TO INCLUDE THE HAZARD INFORMATION.

    Description of Event or Problem · 1

    THE BULK SOLUTIONS ON THE ALINITY CI-SERIES PROCESSING MODULE ARE LOADED INTO THE DOOR OF THE BULK SOLUTION STORAGE AREA. THE BOTTLE IS LOADED BY INVERTING IT AND PLACING IT IN THE APPROPRIATE BOTTLE HOLDER. A SEPTUM ENSURES THE BULK SOLUTION DOES NOT SPILL AS THE BOTTLE IS INVERTED. AS THE BOTTLE IS PLACED INTO THE BOTTLE HOLDER, A SAFETY INTERLOCK IS PUSHED BACK EXPOSING THE SEPTUM PIERCING PROBES TO PUNCTURE THE SEPTUM. WHEN THE BOTTLE RELEASE BUTTON IS DEPRESSED AND THE BOTTLE IS REMOVED, THE SAFETY INTERLOCK SHOULD RE-COVER THE SEPTUM PIERCING PROBES. HOWEVER, IF THE SAFETY INTERLOCK DOES NOT COVER THE SEPTUM PIERCING PROBES, THE PROBES REPRESENT A PROBE STICK HAZARD AS WELL AS A POTENTIAL RISK OF USER SKIN EXPOSURE TO CHEMICALLY HAZARDOUS BULK SOLUTIONS. ABBOTT LABORATORIES HAS IDENTIFIED THAT THE REQUIRED HAZARD LABEL WAS NOT APPLIED TO THE INSTRUMENT BULK SOLUTION AREA OF THE ALINITY I PROCESSING MODULE AND ALINITY C PROCESSING MODULE TO WARN LABORATORY TECHNICIANS ABOUT THE POTENTIAL PROBE STICK AND CHEMICAL EXPOSURE HAZARDS. ADDITIONALLY, INFORMATION REGARDING THE LABEL WAS NOT INCLUDED IN THE OPERATIONS MANUAL TO IDENTIFY THE RISK OF POTENTIAL PROBE STICK AND CHEMICAL EXPOSURE HAZARDS. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT OR SERIOUS INJURY DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205962 ALINITY I PROCESSING MODULE AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT GERMANY 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1