BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 18111413 · Received November 10, 2023

    Report

    Report Number
    3016438761-2023-00549
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    August 18, 2023
    Report Date
    August 15, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3016438761-10/31/23-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR SECTION D: D1 BRAND NAME: ALINITY C PROCESSING MODULE. D4- CATALOG# 03R67-01. D4 UDI: (B)(4). D1 BRAND NAME: ARCHITECT C4000. D4- CATALOG# 02P24-01. D4 UDI: (B)(4). D1 BRAND NAME: ARCHITECT C4000. D4- CATALOG# 02P24-02. D4 UDI: (B)(4). D1 BRAND NAME: ARCHITECT C4000. D4- CATALOG# 02P24-40. D4 UDI: (B)(4). D1 BRAND NAME: ARCHITECT C4000. D4- CATALOG# 01R24-56. D4 UDI:(B)(4). D1 BRAND NAME: ARCHITECT C4000. D4- CATALOG# 01R25-56. D4 UDI: (B)(4). ADDITIONAL INFORMATION FOR SECTION H4 DEVICE MFG DATE: ALINITY I PROCESSING MODULE MANUFACTURING DATE RANGE: 12/23/2016-10/13/2023. ALINITY C PROCESSING MODULE MANUFACTURING DATE RANGE: 01/17/2017-10/13/2023. ARCHITECT C4000 PROCESSING MODULE LN 02P24-01 MANUFACTURING DATE RANGE: 06/11/2009-10/13/2023; LN 02P24-02 MANUFACTURING DATE RANGE: 06/11/2009-10/13/2023; LN 02P24-40 MANUFACTURING DATE RANGE: 06/11/2009-10/13/2023; LN 01R24-56 MANUFACTURING DATE RANGE: 06/11/2009-10/13/2023; LN 01R25-56 MANUFACTURING DATE RANGE: 06/11/2009-10/13/2023. ADDITIONAL INFORMATION FOR H9: 3016438761-10/31/23-001-C. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. A PRODUCT CORRECTION LETTER WAS ISSUED ON 19OCT2023 TO ALL ALINITY I, ALINITY C, AND ARCHITECT C4000 CUSTOMERS, NOTIFYING THEM A PRECAUTIONARY LABEL INDICATING THE PRESENCE OF DRY NATURAL RUBBER (LATEX) WILL BE APPLIED TO THE INSTRUMENT. ADDITIONALLY, THE PRECAUTIONARY LANGUAGE REGARDING DRY NATURAL RUBBER (LATEX) WILL BE ADDED TO A FUTURE VERSION OF EACH PRODUCTS OPERATIONS MANUAL. THE PRODUCT CORRECTION LETTER INFORMS THE CUSTOMER THAT AN ABBOTT REPRESENTATIVE WILL SCHEDULE A SERVICE VISIT WHEN THE INSTRUMENT LABEL IS AVAILABLE FOR APPLICATION AS WELL AS THE NECESSARY ACTIONS TO FOLLOW UNTIL THE LABEL IS APPLIED. H3 OTHER TEXT : THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT BEING SUBMITTED TO PROVIDE ADDITIONAL SERIAL NUMBERS. PLEASE REFER TO THE ATTACHED DOCUMENT FOR ADDITIONAL SNS FOR THE INSTRUMENTS- MDR 3016438761-2023-00549_LIST OF SERIAL NUMBERS.PDF H3 OTHER TEXT : THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED TO CORRECT A STATEMENT PREVIOUSLY POPULATED IN THE H10- ADDITIONAL MFG NARRATIVE SECTION OF THE INITIAL REPORT. THE REPORT INADVERTENTLY INCLUDED ¿A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.¿ THIS STATEMENT IS BEING CORRECTED TO ¿NO SUPPLEMENTAL REPORT IS REQUIRED AS INVESTIGATIONAL FINDINGS WILL BE REPORTED UNDER CORRECTION/REMOVAL REPORT NUMBER 3016438761-10/31/23-001-C WHEN THE INFORMATION IS AVAILABLE.¿ NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 0

    A GLOBAL ASSESSMENT WAS PERFORMED FOLLOWING THE IDENTIFICATION THAT THE ABBOTT ALINITY S SYSTEM CONTAINS A DRY NATURAL RUBBER (LATEX) SUBCOMPONENT, WHICH IS NOT LABELED AS CONTAINING DRY NATURAL RUBBER (LATEX), TO DETERMINE IF THERE IS ANY IMPACT ON OTHER ABBOTT PRODUCTS. THE GLOBAL ASSESSMENT IDENTIFIED THE ALINITY I PROCESSING MODULE, ALINITY C PROCESSING MODULE, AND ARCHITECT C4000 PROCESSING MODULE ALSO INCLUDE INTERNAL HARDWARE PARTS AND/OR SUBASSEMBLIES THAT CONTAIN DRY NATURAL RUBBER (LATEX), BUT DO NOT INCLUDE THE REQUIRED PRECAUTIONARY LABEL. DIRECT CONTACT WITH THESE COMPONENTS HAS THE POTENTIAL TO CAUSE ALLERGIC REACTIONS. THERE HAVE BEEN NO REPORTED OCCURRENCES TO THE DATE OF ADVERSE IMPACT OR HARM TO THE USER/OPERATOR AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 0

    A GLOBAL ASSESSMENT WAS PERFORMED FOLLOWING THE IDENTIFICATION THAT THE ABBOTT ALINITY S SYSTEM CONTAINS A DRY NATURAL RUBBER (LATEX) SUBCOMPONENT, WHICH IS NOT LABELED AS CONTAINING DRY NATURAL RUBBER (LATEX), TO DETERMINE IF THERE IS ANY IMPACT ON OTHER ABBOTT PRODUCTS. THE GLOBAL ASSESSMENT IDENTIFIED THE ALINITY I PROCESSING MODULE, ALINITY C PROCESSING MODULE, AND ARCHITECT C4000 PROCESSING MODULE ALSO INCLUDE INTERNAL HARDWARE PARTS AND/OR SUBASSEMBLIES THAT CONTAIN DRY NATURAL RUBBER (LATEX), BUT DO NOT INCLUDE THE REQUIRED PRECAUTIONARY LABEL. DIRECT CONTACT WITH THESE COMPONENTS HAS THE POTENTIAL TO CAUSE ALLERGIC REACTIONS. THERE HAVE BEEN NO REPORTED OCCURRENCES TO THE DATE OF ADVERSE IMPACT OR HARM TO THE USER/OPERATOR AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805009 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown