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

Catalog Number	06P16-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information for section h4 device mfg date: manufacturing date range: (b)(6) 2016 to (b)(6) 2022.Investigation into the cause of this issue found incorrect standoffs were installed by the supplier, turnamatic.A product correction letter was issued on (b)(6) 2024 to all alinity s system customers with impacted serial numbers, notifying them of the potential hardware issue with the assembly of the alinity s system incubation track.The product correction letter informs the customer that an abbott representative will be performing an inspection of the alinity s system to confirm the five standoffs are correct.If any standoffs are identified as incorrect, the abbott representative will work with the customer to schedule the required service activities to replace these standoffs.There are no additional necessary actions to be taken by the customer.
Event or Problem Description
Abbott has identified a potential issue with hardware associated with the assembly of the alinity s system incubation track.Four standoffs (posts) are utilized to attach the alinity s system incubation track to the system frame.In the instance identified, two of the four standoffs were found to be 5.75 millimeters above specification creating a slight (+0.37o) elevation at one end of the track.This may lead to reaction vessel (rv) jams and/or splashing within the rv as it transitions from the incubation track to the process path during instrument operation.Splashing within an rv has potential to affect test results.There have been no occurrences of incorrect results due to this issue.A fifth standoff is utilized on the alinity s system to attach the rv loader to the frame.The rv loader transitions the rv to the incubation track, which is pre-analytic movement during instrument operation.There would be no impact to assay test results.

• 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: 18654649
• Report Number: 1628664-2024-00002
• Device Sequence Number: 8276833
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 1628664-02/02/2024-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown