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

Model Number	03M7484
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
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.
Event or Problem Description
The customer observed false reactive architect hcv ag results generated on the architect i2000 instrument.The following data was provided: sid (b)(6) initial 4.63 fmol/l, repeat 7.12 fmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) performed troubleshooting and inspected the instrument.The fsr found the position 2 sensor of wash zone 2 was damaged and replaced the part, resolving the issue.No additional discrepant result issues have been reported since the service activity was completed.The instrument service history review revealed no additional service tickets associated with discrepant/erratic 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 did not identify any trends for the complaint issue.The architect i2000sr erratic result rates were within acceptable limits with no trends identified.Labeling was reviewed and found to adequately address the issue under review.The architect system operations manual provides adequate information regarding the troubleshooting of erratic/discrepant results and provides instruction for the removal, replacement, and verification of the arc tbg/sn tp wz.The architect i2000sr service and support manual contained adequate information for the troubleshooting the arc tbg/sn tp wz.Based on all reviewed data, a product deficiency was not identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• 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
• 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: 15420172
• Report Number: 3016438761-2022-00422
• Device Sequence Number: 2621344
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: 00380740107222
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• 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 HCV AG RGT 100T, 06L47-29, 35301LP70; ARC HCV AG RGT 100T, 06L47-29, 35301LP70
• Patient Sex: Unknown