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

Catalog Number	03M74-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
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.Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased architect total psa and architect ca 125 results for patients.The following data was provided: sample id (b)(6), initial total psa result, on (b)(6) 2025, was 1.077, repeat result was 7.590 ng/ml sample id (b)(6), initial ca 125 result, on (b)(6) 2025, was 11.2, repeat result was 39.4 u/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
Field b3 - date of event updated from 2025-04-09 to 2025-04-08.Additional information was provided in field b5 - incident description.An abbott field service representative (fsr) was dispatched due to the customer reporting falsely decreased architect total psa and architect ca 125 results on the architect i2000sr, serial number (b)(6).During an extensive investigation, the fsr discovered the wash zone tube at the thermistor was broken.The fsr replaced the arc tbg/sn tp wz, list number 08c94-90, which resolved the customer¿s complaint.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of tracking and trending for the product and the likely cause lot did not identify an increase in complaint activity.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed falsely decreased architect total psa and architect ca 125 results for patients.The following data was provided: sample id (b)(6) initial total psa result, on (b)(6) 2025, was 1.077, repeat result was 7.590 ng/ml sample id (b)(6) initial ca 125 result, on (b)(6) 2025, was 11.2, repeat result was 39.4 u/ml.It was also noted that the customer experienced instrument error messages before these results were generated.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: 21928869
• Report Number: 3016438761-2025-00253
• Device Sequence Number: 9021823
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/13/2025

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: 03M74-01
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2019
• 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 CA125 RGT(100T), 02K45-29, 67286FP00; ARC CA125 RGT(100T), 02K45-29, 67286FP00; ARC TOTAL PSA 100T JPN, 07K70-27, 72235FZ00; ARC TOTAL PSA 100T JPN, 07K70-27, 72235FZ00
• Patient Sex: Unknown