MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED); ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-40
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased architect troponin result between different tube types drawn at same time from one patient.The result provided were: on (b)(6) 2025 sid (b)(6) initial from yellow tube specimen=0.075 ng/ml /repeated=0.297 ng/ml green tube specimen drawn at same time= < 0.010 ng/ml /repeated= < 0.010 ng/ml the customer concerned for this green tube type specimen results/ redrawn green tube specimen sid (b)(6) initial=0.029 ng/ml /repeated=0.030 ng/ml redrawn green tube specimen sid (b)(6) =0.079 ng/ml.Yellow tube specimen=0.062 ng/ml.Laboratory reference range for troponin= < or =0.050 ng/ml; > 0.050 ng/ml consider cardiac event.There was no reported impact to patient management.
Additional Manufacturer Narrative
This follow-up submission being send to cross reference mdr -01 for likely cause changed on (b)(6) 2025; architect i1000sr processing module, list number 01l86-40 to architect troponin reagent, list number 02k41-27.All further information will be submitted under mdr 1415939-2025-00031-00.
Event or Problem Description
The customer observed falsely decreased architect troponin result between different tube types drawn at same time from one patient.The result provided were: on (b)(6) 2025 sid (b)(6) initial from yellow tube specimen=0.075 ng/ml /repeated=0.297 ng/ml green tube specimen drawn at same time= < 0.010 ng/ml /repeated= < 0.010 ng/ml.The customer concerned for this green tube type specimen results/ redrawn green tube specimen sid (b)(6) initial=0.029 ng/ml /repeated=0.030 ng/ml, redrawn green tube specimen sid (b)(6) =0.079 ng/ml, yellow tube specimen=0.062 ng/ml.Laboratory reference range for troponin= < or =0.050 ng/ml; > 0.050 ng/ml consider cardiac event.There was no reported impact to patient management.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 23168646
• Report Number: 3016438761-2025-00561
• Device Sequence Number: 9639549
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/07/2025

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: 01L86-40
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC TROP RGT, 02K41-27,; ARC TROP RGT, 02K41-27,
• Patient Sex: Unknown