MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	03M7484
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was instructed to troubleshoot the instrument which included: flushing solutions, inspecting the wash zones, and calibrating the sample and reagent probes.There have been no further reports of discrepant results since the troubleshooting by the customer was performed.A review of the architect sn# (b)(4) service history was not able to identify or confirm any additional likely causes.A review of historical data revealed no trends, systemic issues, or related nonconformances.A review of the clinical chemistry systems revealed found no systemic issues or trends for the issue associated with this ticket (erratic/discrepant results).Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of labelling adequately addresses sample results observed problems for erratic / discrepant results.Based on the investigation no systemic issue or deficiency was identified for the architect i2000sr analyzer.Patient identifier complete sid:(b)(6).
Event or Problem Description
The customer reported a (b)(6) architect total b-hcg result on a patient.Results provided: sid (b)(6), cartridge and rapid tests are both negative.No impact to patient management was reported.

• 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
• MDR Report Key: 12647842
• Report Number: 3016438761-2021-00377
• Device Sequence Number: 1205585
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: 00380740107222
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: 03M7484
• Device Catalogue Number: 03M74-84
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1