MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE, REFURBISHED; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-84
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive architect syphilis tp results on a patient that was nonreactive on the cobas platform.The results provided were: on (b)(6) 2025, sid (b)(6), initial=1.57 s/co (> or = 1.00 s/co=reactive) /repeated=1.62 and 1.21 s/co /repeated on (b)(6) 2025=1.21 s/co /on cobas 300=0.05 s/co (negative).Additional information provided: immunofluorescence (anti-tp) = negative there was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
This follow-up submission sends for additional information received on 23jun2025; the likely cause product has been changed from the architect i1000sr processing module to the architect syphilis tp reagent on (b)(6) 2025.The us list number (8d06-31/41) is a diagnostic assay, not intended for use in screening blood, plasma, or tissue donors, therefore, this event does not meet reporting criteria in the u.S, therefore no mdr was generated., therefore, no investigation report will be provided for architect syphilis tp reagent, list number 08d06-32, lot number 67727be00.
Event or Problem Description
The customer observed false reactive architect syphilis tp results on a patient that was nonreactive on the cobas platform.The results provided were: on (b)(6) 2025 sid (b)(6) initial=1.57 s/co (> or = 1.00 s/co=reactive) /repeated=1.62 and 1.21 s/co /repeated on (b)(6) 2025=1.21 s/co /on cobas 300=0.05 s/co (negative) additional information provided: immunofluorescence (anti-tp) = negative there was no reported impact to patient management.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE, REFURBISHED
• 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: 22134832
• Report Number: 3016438761-2025-00327
• Device Sequence Number: 7487088
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: (01)00380740116941
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 01L86-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC SYPHILIS TP 100T, 08D06-32, 67727BE00; ARC SYPHILIS TP 100T, 08D06-32, 67727BE00
• Patient Sex: Unknown