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	02/28/2024
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.Complete information for section a1 patient identifier = sid (b)(6).
Event or Problem Description
The customer observed false positive results for architect syphilis tp and hiv ag/ab combo on the architect i2000sr, serial number (b)(6), for 4 patients.The following data was provided: syphilis: sid (b)(6) processed on (b)(6) 2024 result = 3.02 s/co repeated and result unchanged(positive).New collection same patient sid (b)(6) processed on (b)(6) 2024 = 0.00 s/co negative sid (b)(6) processed on (b)(6) 2024 result = 21.58 s/co repeated and result unchanged(positive).New collection same patient same day sid (b)(6) result = 0.09 s/co negative sid (b)(6) processed on 28feb2024 result = 20.49 s/co repeated and result unchanged(positive).New collection same patient sid (b)(6) processed on (b)(6) 2024 = 0.10 s/co negative new collection same patient sid (b)(6) processed on (b)(6) 2024 = 0.10 s/co negative hiv: sid (b)(6) processed on (b)(6) 2024 result = 15.61 s/co repeat result = 17.70 s/co new collection result = 0.07 s/co no impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed.Service checked and cleaned multiple parts when troubleshooting the issue but found no identifiable part specific issues; therefore, the architect i2000sr, serial # (b)(6) was deemed the likely cause for the issue.However, sample integrity could not be ruled out.The service history of the (b)(6) verifies no subsequent issues have been reported related to the complaint issue.Trending review did not identify any trends.Device history record review did not identify any non-conformances or deviations with the architect i2000sr processing module and the complaint issue.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no deficiency was identified.
Event or Problem Description
The customer observed false positive results for architect syphilis tp and hiv ag/ab combo on the architect i2000sr, serial number (b)(6), for 4 patients.The following data was provided: syphilis: sid (b)(6) processed on (b)(6) 2024 result = 3.02 s/co repeated and result unchanged(positive).New collection same patient sid (b)(6) processed on (b)(6) 2024 = 0.00 s/co negative.Sid (b)(6) processed on (b)(6) 2024 result = 21.58 s/co repeated and result unchanged(positive).New collection same patient same day sid (b)(6) result = 0.09 s/co negative.Sid (b)(6) processed on (b)(6) 2024 result = 20.49 s/co repeated and result unchanged(positive).New collection same patient sid (b)(6) processed on (b)(6) 2024 = 0.10 s/co negative.New collection same patient sid (b)(6) processed on (b)(6) 2024 = 0.10 s/co negative.Hiv: sid (b)(6) processed on (b)(6) 2024 result = 15.61 s/co repeat result = 17.70 s/co.New collection result = 0.07 s/co 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: 18971082
• Report Number: 3016438761-2024-00175
• Device Sequence Number: 6035796
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 04/05/2024

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): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC HIV AG/AB RGT, 04J27-32,58532BE00; ARC HIV AG/AB RGT, 04J27-32,58532BE00; ARC SYPHILIS TP 500T, 08D06-42,54394BE00; ARC SYPHILIS TP 500T, 08D06-42,54394BE00
• Patient Sex: Unknown