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

Catalog Number	03M74-01
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed architect anti-hbc ii results generated on the architect i2000sr processing module for one sample.The following results were provided: initial result = 0.1, repeat result = 5.0.The customer believes the reactive result is correct.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section d10 concomitant product, corrected information in section e1 last name.The field service representative was troubleshooting the issue observed foam/bubbles in the valve, manifold kit and fitting kit, trigger_pre-trigger of the architect i2000sr processing module.The field service representative replaced both the valve, manifold kit (rohs and fitting kit, trigger_pre-trigger (rohs) and deemed the parts the likely cause for the false depressed anti-hbc ii results.Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not completed as returns were not available.The service history of the (b)(6) found no additional falsely depressed anti-hbc ii results were reported post the current event was identified.A review of tracking and trending did not identify any trends for the valve, manifold kit and fitting kit, trigger_pre-trigger, or the architect i2000sr processing module.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the available information, no systemic issue or deficiency of the architect i2000sr processing module for serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed architect anti-hbc ii results generated on the architect i2000sr processing module for one sample.The following results were provided: initial result = 0.1, repeat result = 5.0.The customer believes the reactive result is correct.No impact to patient management was 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: 20667454
• Report Number: 3016438761-2024-00659
• Device Sequence Number: 12821451
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/21/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2015
• 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: FITTING KIT, TRIGGER_PRE-TRIGGER (ROHS), 7-77664-0; VALVE, MANIFOLD KIT (ROHS), 7-77612-04, UNKNOWN; VALVE, MANIFOLD KIT (ROHS), 7-77612-04, UNKNOWN
• Patient Sex: Unknown