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

Model Number	3M74-98
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false positive architect sars-cov-2 igg result for one patient sample.The following results were provided: on (b)(6) 2023 sid (b)(6): initial sars-cov-2 igg result = 2.58 index; repeat result = 0.54 index (reference range: < 1.4 index is negative, >/= 1.4 index is positive) the customer stated qc for sars-cov-2 igg was within range.The customer also stated the qc was out of range for their cov-2 igg ii negative control however when repeated was within range (initial = 656 au/ml; repeat = 5.8 au/ml).There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 patient identifier: sid (b)(6) (the complete sid, since it was too long and exceeded the amount of characters it can hold).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false positive architect sars-cov-2 igg result for one patient sample.The following results were provided: on (b)(6) 2023 sid (b)(6): initial sars-cov-2 igg result = 2.58 index; repeat result = 0.54 index (reference range: < 1.4 index is negative, >/= 1.4 index is positive).The customer stated qc for sars-cov-2 igg was within range.The customer also stated the qc was out of range for their cov-2 igg ii negative control however when repeated was within range (initial = 656 au/ml; repeat = 5.8 au/ml).There was no impact to patient management reported.
Additional Manufacturer Narrative
The field service engineer (fse) performed troubleshooting on the architect i2000sr, serial number (b)(6), replacing several parts including the syringe assy.The assembly was determined the likely cause for the discrepant results.Quality control was performed after part replacement and found within acceptable limits.There was no impact to patient management reported.A review of the architect i2000sr, sn (b)(6), service history identified no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.The review of tracking and trending did not identify any related trends for the syringe assy or the architect i2000sr.A review of the device history records did not identify any non-conformances or deviations related to the syringe assy or the architect i2000sr analyzer.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified.

• 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: 17263511
• Report Number: 3016438761-2023-00361
• Device Sequence Number: 7882786
• Product Code: JJE
• UDI-Device Identifier: 00380740068851
• UDI-Public: 00380740068851
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/14/2023

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: 3M74-98
• Device Catalogue Number: 03M74-98
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2005
• 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 COV2 IGG 100T OUS, 06R86-22, 49461FN00.; ARC COV2 IGG 100T OUS, 06R86-22, 49461FN00.
• Patient Sex: Unknown