MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	06P16-01
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information for section h4 device mfg date: manufacturing date range: 12/21/2016-10/16/2023.The investigation is ongoing.A supplemental report will be submitted upon completion.A product correction letter was issued on 19oct2023 to all alinity s system 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 the alinity s system 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.
Event or Problem Description
Abbott has identified the alinity s system contains a latex subcomponent and is not labeled as containing latex.Precautionary labeling is being added to the alinity s system to inform the users of the presence of dry natural rubber (latex).The alinity s system solid waste container rubber band (ln 04u97-01) used to secure the biohazard bag to the solid waste container, and internal hardware parts and/or subassemblies, contain dry natural rubber (latex).Direct contact with these components has the potential to cause allergic reactions.There has been no reported occurrences of the issue to date of adverse impact or harm to the user/operator as a result of this issue.
Additional Manufacturer Narrative
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 1628664-10/31/23-001-c when the information is available.No further information will be provided under this manufacturer report number.
Event or Problem Description
Abbott has identified the alinity s system contains a latex subcomponent and is not labeled as containing latex.Precautionary labeling is being added to the alinity s system to inform the users of the presence of dry natural rubber (latex).The alinity s system solid waste container rubber band (ln 04u97-01) used to secure the biohazard bag to the solid waste container, and internal hardware parts and/or subassemblies, contain dry natural rubber (latex).Direct contact with these components has the potential to cause allergic reactions.There has been no reported occurrences of the issue to date of adverse impact or harm to the user/operator as a result of this issue.

• Brand Name: ALINITY S SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18111294
• Report Number: 1628664-2023-00011
• Device Sequence Number: 14841946
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: (01)00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1628664-10/31/23-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown