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

Model Number 06P1601

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false reactive alinity s hiv ag/ab combo results for three patients.The samples were repeated on another instrument which generated nonreactive results.The following data was provided: (b)(6) 2022 sid (b)(6).Initial result = 2.32 s/co (reactive), repeat results = 1.42, 1.78, 1.88, 2.40 s/co (all reactive).Sample repeated on another instrument (as1403) result = 0.43 s/co (nonreactive).Repeat result post troubleshooting = 0.35 s/co (nonreactive).(b)(6) 2022 sid (b)(6).Initial result = 1.25 s/co (reactive), repeat results = 3.81, 2.83, 1.53, 1.00 s/co (all reactive).Sample repeated on another instrument (as1403) result = 0.42 s/co (nonreactive).Repeat result post troubleshooting = 0.44 s/co (nonreactive).(b)(6) 2022 sid (b)(6).Initial result = 1.83 s/co (reactive), repeat results = 1.63, 2.58, 3.64 s/co (all reactive).Sample repeated on another instrument (as1403) result = 0.46 s/co (nonreactive).Repeat result post troubleshooting = did not repeat due to insufficient sample volume.No impact to patient management was reported.

Manufacturer Narrative

The abbott ambassador inspected the analyzer and performed instrument troubleshooting inclusive of precision checks, wash zone and optics cleaning, and probe straightness.The abbott ambassador identified the sample pipettor probe 2 was not straight and it was replaced.The replacement of the pipettor probe resolved the issue and therefore the pipettor probe was determined to be the likely issue of the issue.Two of the donor samples were retested after troubleshooting and the results were nonreactive.The third sample was not retested because of inadequate sample volume.The pictures of the results list report documents and file of sample results were provided.An instrument service history review for (b)(6) identified no contributing factors to the current complaint and no additional occurrences of false reactive results have been documented.Ticket trending was reviewed and identified no additional complaints similar to the issue described in the current complaint.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.Additionally, a review of the transfusion product monitoring tracking and trending data did not identify any systemic issues or trends related to the complaint issue.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.

• Brand Name: ALINITY S SYSTEM
• Type of Device: 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: 15956265
• MDR Text Key: 308528744
• Report Number: 1628664-2022-00028
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (y/n): N
• Reporter Country Code: AJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06P1601
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S HIV COMBO RGT, 06P01-55, 42225BE00; ALNTY S HIV COMBO RGT, 06P01-55, 42225BE00