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	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false positive troponin result generated on an architect i1000sr processing module for one patient.The initial result = 1190 ng/l, repeat result = 5.25 ng/l.The patient was redrawn, and the sample generated a result = 1.8 ng/l.The customer¿s normal range is <30 ng/l.There was no impact to patient management.
Additional Manufacturer Narrative
This issue was previously reported under mdr number 168664-2021-00008 under the same suspect medical device but an incorrect manufacturer name, city and state.Service recommended the customer replace the arc, probe and recalibrate.The customer did not change the probe but recalibrated it, which resolved the issue.No additional discrepant result issues have been reported since the part was recalibrated.The instrument service history review revealed no additional service 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.Trending review for the arc, probe did not identify any trends.A review of tracking/trending for alinity i/architect ia found no similar issues related to the architect system, parts, or discrepant results as described in this complaint.The architect i1000sr erratic result rates were within acceptable limits with no trends identified.Device history record review did not identify any non-conformances or potential non-conformances for the parts associated with this complaint.Labeling was reviewed and adequately addresses the issue.Based on the investigation, no systemic issue or deficiency of the architect i1000sr, serial number i1sr52447, 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: 17670147
• Report Number: 3016438761-2023-00465
• Device Sequence Number: 15230134
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: 00380740116941
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/01/2023

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: 08/30/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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: RGT ARCH TROPONIN 100T, 03P25-27.
• Patient Sex: Unknown