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	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number 03m74-01 that has a similar product distributed in the us, list number 3m74-02 / 84 / 98, with 510k/pma/bla of exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false reactive architect hiv ag/ab combo for multiple patients.The patients with initial reactive hiv results are recentrifuged and repeated with reactive results.When the same patients were repeated on the roche cobas, the results were negative.There were no specific patient results provided.There was no impact to patient management reported.
Event or Problem Description
The customer observed false reactive architect hiv ag/ab combo for multiple patients.The patients with initial reactive hiv results are recentrifuged and repeated with reactive results.When the same patients were repeated on the roche cobas, the results were negative.There were no specific patient results provided.There was no impact to patient management reported.
Additional Manufacturer Narrative
Updated to include h4: device mfg date.
Additional Manufacturer Narrative
After further evaluation, the likely cause is being changed from the architect i2000sr to the architect hiv ag/ab combo reagent (list number 04j27).False reactive architect hiv ag/ab combo results generated for diagnostic purposes only is not reportable.Based upon this new information, this complaint is no longer a reportable event.
Event or Problem Description
The customer observed false reactive architect hiv ag/ab combo for multiple patients.The patients with initial reactive hiv results are recentrifuged and repeated with reactive results.When the same patients were repeated on the roche cobas, the results were negative.There were no specific patient results provided.There was no impact to patient management reported.
Additional Manufacturer Narrative
Upon further review, on 10dec2024, the likely cause product was changed to the architect i2000sr processing module, list number 03m74, and therefore further information will be provided under this product.The field service representative inspected the architect i2000sr analyzer and cleaned the clogged asm waste manifold.The cleaning of the asm waste manifold resolved the issue.Return testing was not completed as returns were not available.The instrument service history review revealed no additional service tickets associated with discrepant/erratic patient results.There were 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 tracking and trending of the architect i2000sr did not identify any trends associated with the complaint issue.A review of tracking and trending for the asm waste manifold did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i2000sr analyzer for serial (b)(6) or the asm waste manifold was identified.
Event or Problem Description
The customer observed false reactive architect hiv ag/ab combo for multiple patients.The patients with initial reactive hiv results are recentrifuged and repeated with reactive results.When the same patients were repeated on the roche cobas, the results were negative.There were no specific patient results provided.There was no impact to patient management reported.

• 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: 20785913
• Report Number: 3016438761-2024-00681
• Device Sequence Number: 7809827
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 12/26/2024

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
• Device Lot Number: ISR08262
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 12/10/2024; 12/26/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/04/2024; 12/26/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2011
• 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, 65011BE00; ARC HIV AG/AB RGT 100T, 04J27-27, 65011BE00; ARC HIV AG/AB RGT 100T, 04J27-27, 65011BE00; ARC HIV AG/AB RGT 100T, 04J27-27, 65011BE00; MANIFOLD, WASTE ASM, 7-78349-01,
• Patient Sex: Unknown