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

Catalog Number	01L86-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Aduring the requested site visit, the field service representative (fsr) inspected the instrument and resolved the issue by cleaning the dirty cmia wash tubing (rohs) (7-203686-01).A review of the architect i1000sr processing module, serial number (b)(6) service history was performed and no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect i1000sr processing module did not identify any similar issues as described in this complaint.Additionally review of complaint and trending data associated with the architect cmia wash tubing did not identify an increase in complaint activity.The architect system operations manual provides adequate information regarding the troubleshooting of erratic/discrepant results.The architect i1000sr service and support manual provides instruction for the removal, replacement, and verification of the cmia wash tubing (rohs) (7-203686-01).A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation no product deficiency was identified for either the architect i1000sr processing module, serial number (b)(6), or cmia wash tubing.
Event or Problem Description
The customer observed false repeat reactive architect hiv ag/ab combo results on multiple patients that negative on other methods.The results provided were: patient 1: initial=1.60 s/co (> or = 1.00 s/co=reactive) /repeated=1.57 s/co /on architect i2sr=0.20 s/co (< 1.00 s/co=nonreactive) /colloidal gold standard method=negative.Patient 2: initial=2.19 s/co /repeated=2.21 s/co /on architect i2sr=0.14 s/co /colloidal gold standard method=negative.Patient 3: initial=1.40 s/co /repeated=1.16 s/co /on architect i2sr=0.17 s/co /colloidal gold standard method=negative.Patient 4: initial=2.00 s/co /repeated=2.20 s/co /on architect i2sr=0.20 s/co /colloidal gold standard method=negative there was no reported impact to patient management.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE
• 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: 21642811
• Report Number: 3016438761-2025-00171
• Device Sequence Number: 18067420
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/19/2025

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: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2013
• 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 HIV AG/AB 100T CN, 04J27-84, 58544BE00
• Patient Sex: Unknown