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

Catalog Number	01L86-84
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i.The customer reported 3 events have occurred since (b)(6) 2023 and reported that two samples were reported out of the laboratory.The customer provided the following data: (customer normal range = 0.0-0.03 ng/ml).On 26 july 2023 sample id (b)(6) initial result was 0.04, repeat result was 0.03, repeat result on another analyzer was 0.03.On 3 aug 2023 sample id (b)(6) initial result was 0.05, repeat result was 0.03, repeat result on another analyzer was 0.03.There was no reported impact to patient management.
Additional Manufacturer Narrative
A1 patient identifier: complete sample ids are (b)(6).All available patient information was included.Additional patient details are not available.The field service representative (fsr) inspected the architect i1000sr, serial number (b)(6) and resolved the issue by replacing the assy, manifold wz fep tips, with valves (rohs) as buildup was observed under the part.No additional discrepant result issues have been reported since the service activity was completed.Return testing was not completed as returns were not available.The instrument service history review revealed no additional issues related to 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.A review of tracking and trending was performed for the assy, manifold wz fep tips, with valves (rohs) and the product monitoring review scorecard was reviewed and found no similar issues related to the architect system or discrepant results with regards to the customer issue.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the assy, manifold wz fep tips, with valves (rohs).A labeling review determined product labeling addresses troubleshooting and resolution of the customer issue.Based on the available information, no systemic issue or deficiency of the architect i1000sr, serial number (b)(6) and the assy, manifold wz fep tips, with valves (rohs) was identified.

• Brand Name: ARCHITECT I1000SR
• 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: 17662682
• Report Number: 3016438761-2023-00461
• Device Sequence Number: 7123999
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: 00380740116941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/31/2023

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: 01L86-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• 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, 40797UN23
• Patient Sex: Unknown