MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false reactive architect hiv ag/ab combo results on a patient that was not reported out of the laboratory.The following results were provided: (b)(6) 2024 sid (b)(6) serum = 4.1 s/co; edta plasma = 1.8 s/co, siemens platform is negative.No impact to patient management was reported.
Additional Manufacturer Narrative
Although a definitive cause for the issue was not identified, the architect (b)(6) was considered the likely cause for the issue.A review of the architect sn# (b)(6) service history was not able to identify or confirm any additional likely causes.A review of historical data revealed no trends, systemic issues, or related non-conformances.A review of the clinical chemistry systems revealed found no systemic issues or trends for the issue associated with this ticket (erratic/discrepant results).Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of labelling adequately addresses sample results observed problems for erratic / discrepant results.Based on the investigation no systemic issue or deficiency was identified for the architect i2000sr analyzer.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT I2000SR
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19938630
• Report Number: 3016438761-2024-00460
• Device Sequence Number: 20052741
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 08/08/2024

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: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2006
• 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: ARC HIV AG/AB RGT 100T, 04J27-27, (B)(6)
• Patient Sex: Unknown