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

Model Number	06P1601
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hcv ii results for two donors.Since two plasma samples were taken from each donor, the customer performed testing on the second sample which generated nonreactive results.Carryover contamination is suspected as the preceding sample was a reactive sample.The following data was provided: (b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = both reactive, single pcr hcv result = positive.Sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii, single pcr hcv result = negative, hcv-lia result = negative.(b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = one reactive, one nonreactive, single pcr hcv result = positive.Sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii, single pcr hcv: negative, hcv-lia: negative, no impact to donor management was reported.
Additional Manufacturer Narrative
The abbott ambassador performed instrument troubleshooting and q1 system maintenance.In addition, the wash zones were checked and cleaned, and the syringe pump connected to the sample pipettor 1 was replaced.An instrument service history review for (b)(6) did not identify any additional instances of the current issue.A review of the complaints data for the alinity s system revealed no trends or systemic issue associated with the alinity s system nor identified any additional complaints associated with carry-over issues.Additionally, a review of product monitoring review (pmr) metrics identified no trends for the alinity s system or the customer concern as described in this complaint text.The device history record was reviewed and did not identify any non-conformances, potential non-conformances or deviations related to the issue described in the current complaint.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity s system for serial number (b)(6) was identified.
Event or Problem Description
The customer observed false repeat reactive alinity s anti-hcv ii results for two donors.Since two plasma samples were taken from each donor, the customer performed testing on the second sample which generated nonreactive results.Carryover contamination is suspected as the preceding sample was a reactive sample.The following data was provided: (b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = both reactive single pcr hcv result = positive sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii single pcr hcv result = negative hcv-lia result = negative (b)(6) 2023 sid (b)(6): sample 1 initial alinity s anti-hcv ii result = reactive; repeat in duplicate = one reactive, one nonreactive single pcr hcv result = positive sample 2 ran in triplicate = all nonreactive for alinity s anti-hcv ii single pcr hcv: negative hcv-lia: negative no impact to donor management was reported.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16728852
• Report Number: 1628664-2023-00004
• Device Sequence Number: 17802672
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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 Model Number: 06P1601
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALIN S ANTI HCVII 2500T, 04W56-56, 45373BE00; ALIN S ANTI HCVII 2500T, 04W56-56, 45373BE00
• Patient Sex: Unknown