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	01/15/2022
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.Patient identifier sids: (b)(6).
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i results on two patients.Results provided: (b)(6) 2022 sid (b)(6) = 16.959 / 0.012 ng/ml; (b)(6) 2022 sid (b)(6) = 17.212 / 0 ng/ml.Normal range: 0.000-0.045 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
During the subsequent site visit by the field service engineer (fse), the manifold for the wash zone was replaced along with other parts.The fse determine the manifold was the likely cause.A review of the analyzer service history identified no contributing factors to the current complaint.There have been no further occurrences of discrepant results after the parts were replaced by the fse.A review of labeling concluded that the issue is sufficiently addressed.A review of the architect i1000sr platform and the associated replaced parts tracking and trending data revealed no systemic issues or trends associated with the discrepant results described in this complaint.Based on the investigation no systemic issue or product deficiency was identified.Section b5.Additional patient added on (b)(6) 2022: sid (b)(6) = 27.36 / 0.006 / 0.000 ng/ml.
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i results on three patients.Results provided: (b)(6) 2022 sid (b)(6) = 16.959 / 0.012 ng/ml; (b)(6) 2022 sid (b)(6) = 17.212 / 0 ng/ml.Normal range: 0.000-0.045 ng/ml.Additional patient added on (b)(6) 2022: sid (b)(6) = 27.36 / 0.006 / 0.000 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
During the subsequent site visit by the field service engineer (fse), the manifold for the wash zone was replaced along with other parts.The fse determine the manifold was the likely cause.A review of the analyzer service history identified no contributing factors to the current complaint.There have been no further occurrences of discrepant results after the parts were replaced by the fse.A review of labeling concluded that the issue is sufficiently addressed.A review of the architect i1000sr platform and the associated replaced parts tracking and trending data revealed no systemic issues or trends associated with the discrepant results described in this complaint.Based on the investigation no systemic issue or product deficiency was identified.Section a1 patient identifier sids: (b)(6).Additional patient added on 07feb2022: sid (b)(6) = 27.36 / 0.006 / 0.000 ng/mlit was discovered on august 30, 2023 that the initial emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 3016438761-2023-00468 has been submitted for the correct manufacturing site and all further information will be documented under that mdr.
Event or Problem Description
The customer reported falsely elevated architect stat troponin-i results on three patients.Results provided: 15jan2022 sid (b)(6) = 16.959 / 0.012 ng/ml; 17jan2022 sid (b)(6) = 17.212 / 0 ng/ml.Normal range: 0.000-0.045 ng/ml.Additional patient added on 07feb2022: sid (b)(6) = 27.36 / 0.006 / 0.000 ng/ml.No impact to patient management was reported.

• 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 ; 433331157
• MDR Report Key: 13455793
• Report Number: 1628664-2022-00009
• Device Sequence Number: 5785541
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: 00380740116941
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 02/07/2022; 08/30/2023
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/14/2022; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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, 81264UN21; ARC TROP RGT, 02K41-27, 81264UN21; ARC TROP RGT, 02K41-27, 81264UN21
• Patient Sex: Unknown