MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; 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	08/15/2023
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.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results for 1 patient.The patient¿s next two samples were lower.The original sample was repeated and the result was also lower.The following data was provided: processed on (b)(6) 2023 result = 0.13 ng/ml.2 new samples collected later in the day and both results negative all 3 samples repeated on two architects and all 6 results were negative(near zero).Troponin reference range = 0.04 ng/ml no impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results for 1 patient.The patient¿s next two samples were lower.The original sample was repeated and the result was also lower.The following data was provided: processed on (b)(6) 2023 result = 0.13 ng/ml 2 new samples collected later in the day and both results negative all 3 samples repeated on two architects and all 6 results were negative(near zero).Troponin reference range = <0.04 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument, architect (b)(6), serial # (b)(6), and performed extensive troubleshooting, replacing multiple parts.However, the wz manifold with valves, fep tips (rohs)_part number 7-96263-06 was deemed the likely cause for the issue.The issue was considered resolved with the replacement of the wz manifold with valves, fep tips (rohs).The service history of the (b)(6) verifies no subsequent false elevated troponin patient results have been reported.A review of tracking and trending of the wz manifold with valves, fep tips (rohs)_part number 7-96263-06 did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c4000 i2000sr, serial # (b)(6), or wz manifold with valves, fep tips (rohs)_part number 7-96263-06 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17683109
• Report Number: 3016438761-2023-00474
• Device Sequence Number: 6281531
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: 00380740107222
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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 TROP RGT, 02K41-27,; ARC TROP RGT, 02K41-27,
• Patient Sex: Unknown