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

Catalog Number	03M74-84
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated troponin-i stat high sensitivity results for a 74-year-old male patient that is currently still hospitalized in the intensive care unit (icu).(lab cutoff is >35 ng/l is critical) the following results were provided: initial troponin result = 59 ng/l, serial blood draws 2 hours apart results = 276 ng/l, 20 ng/l repeated same instrument with results = 29.8 ng/l, 85.0 ng/l, 119.0 ng/l draws 4 and 5 all below their cutoff at approximately 16 ng/l all draws were repeated on secondary instrument with results <35 ng/l no impact to patient management was reported.
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.
Additional Manufacturer Narrative
Additional information in section b3 date of event the field service representative (fsr) inspected the architect i2000sr processing module, determined the arc tbg/sn tp wz was worn and replaced the part.The replacement of the part resolved the issue.The instrument service history review revealed no additional 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.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect i2000sr processing module did not identify any similar issues related to the current issue.Additionally review of complaint and trending data associated with arc tbg/sn tp wz did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances and potential non-conformances related to the current issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i2000sr processing module for serial number (b)(6) or the arc tbg/sn tp wz was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated troponin-i stat high sensitivity results for a 74-year-old male patient that is currently still hospitalized in the intensive care unit (icu).(lab cutoff is >35 ng/l is critical) the following results were provided: initial troponin result = 59 ng/l, serial blood draws 2 hours apart results = 276 ng/l, 20 ng/l repeated same instrument with results = 29.8 ng/l, 85.0 ng/l, 119.0 ng/l.Draws 4 and 5 all below their cutoff at approximately 16 ng/l.All draws were repeated on secondary instrument with results <35 ng/l.No impact to patient management was reported.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED
• 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: 23767993
• Report Number: 3016438761-2025-00712
• Device Sequence Number: 10631277
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: (01)00380740107222
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/19/2025

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: 03M74-84
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2017
• 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 TBG/SN TP WZ, 08C94-90, UNKNOWN.; ARC TBG/SN TP WZ, 08C94-90, UNKNOWN.; ARC TROPONIN HS RGT 100, 02R98-25, UNKNOWN.; ARC TROPONIN HS RGT 100, 02R98-25, UNKNOWN.
• Patient Age: 74 YR
• Patient Sex: Male