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

Catalog Number	03M74-02
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false nonreactive architect hiv ag/ab combo results generated on the architect i2000sr instrument for one sample.The sample was repeated in duplicate on another analyzer and the results were reactive.No impact to patient management was reported.
Event or Problem Description
The customer observed false nonreactive architect hiv ag/ab combo results generated on the architect i2000sr instrument for one sample.The sample was repeated in duplicate on another analyzer and the results were reactive.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ph of the wash buffer was checked and found to be 10 (expected ph 7.0 to 7.6).It was stated that the customer incorrectly prepared the wash buffer by using the trigger solution instead of the architect concentrated wash buffer solution.Therefore, this is considered a use error.The ticket trending review of at least 12 months complaint data for the list number did not identify any trend regarding commonalities for lot number and issue.A review of the labelling addresses the customer¿s issue.A malfunction was not identified, based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.A systemic issue and/or product deficiency was not identified.In this case a user error was identified.

• Brand Name: ARCHITECT I2000SR 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: 21697941
• Report Number: 3016438761-2025-00190
• Device Sequence Number: 15761635
• Product Code: JJE
• UDI-Device Identifier: 00380740003890
• UDI-Public: (01)00380740003890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 03M74-02
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 COMBO100T, 02P36-25, (B)(6); ARC HIV COMBO100T, 02P36-25, (B)(6)
• Patient Sex: Unknown