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

Model Number	01L8684
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for patient identification: sids(b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated architect stat troponin-i result for multiple patient samples.The following data was provided (customer¿s reference range >/= 0.04 ng/ml - positive, <0.04 ng/ml - negative): sample id (b)(6), (b)(6) 2023 initial result = 0.04 ng/ml, repeat = 0.03 ng/ml, 0.02 ng/ml.Sample id (b)(6), (b)(6) 2023 initial result = 0.4 ng/ml, repeat = 0.03 ng/ml, 0.03 ng/ml.Sample id (b)(6), (b)(6) 2023 initial result = 0.04 ng/ml, repeat = 0.31 ng/ml.No impact to patient management was provided.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date.The field service representative (fsr) inspected the instrument, performed troubleshooting and determined the arc snsr lvl trig was the likely cause of the issue as it was found to be cracked.The part was replaced, and the issue was resolved as no additional discrepant results have been reported since the service activity was completed.Return testing was not completed as returns were not available.An instrument service history review revealed no additional erratic or discrepant patient results reported for (b)(6).A review of tracking and trending of the architect i1000sr did not identify any trends associated with the complaint issue.A review of tracking and trending for the arc snsr lvl trig did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Device history record review did not show any non-conformances or potential non-conformances.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i1000sr for serial (b)(6), or the arc snsr lvl trig, was identified.
Additional Manufacturer Narrative
It was discovered on august 30, 2023 that the initial and supplemental emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 3016438761-2023-00469-00 has been submitted for the correct manufacturing site and all further information will be documented under that mdr.
Event or Problem Description
The customer observed a falsely elevated architect stat troponin-i result for multiple patient samples.The following data was provided (customer¿s reference range >/= 0.04 ng/ml - positive, <0.04 ng/ml - negative): sample id (b)(6) (b)(6) 2023 initial result = 0.04 ng/ml, repeat = 0.03 ng/ml, 0.02 ng/ml.Sample id (b)(6) (b)(6) 2023 initial result = 0.4 ng/ml, repeat = 0.03 ng/ml, 0.03 ng/ml.Sample id (b)(6) (b)(6) 2023 initial result = 0.04 ng/ml, repeat = 0.31 ng/ml.No impact to patient management was provided.

• Brand Name: ARCHITECT I1000SR
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16629840
• Report Number: 1628664-2023-00003
• Device Sequence Number: 4511902
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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 Model Number: 01L8684
• Device Catalogue Number: 01L86-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 08/30/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/12/2023; 09/01/2023
• 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, (B)(6) ; ARC TROP RGT, 02K41-27, (B)(6) ; ARC TROP RGT, 02K41-27, (B)(6)
• Patient Sex: Unknown