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

Model Number	3M74-98
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.An abbott field service representative (fsr) was dispatched due to the customer reporting a false negative architect sars-cov-2 igg result on the architect i2000sr, serial number (b)(4).Through an extensive investigation, the fsr found the syringe assy, part number 7-77650-08, needed to be replaced, which resolved the customer¿s complaint.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency was identified.
Event or Problem Description
The customer observed a false negative sars-cov-2 igg result for one patient on an architect i2000sr analyzer.The following data was provided (<1.4 index is negative, >/=1.4 index is positive): sample id (b)(6) initial result, on (b)(6) 2021, was 2.16, repeats were 0.52 and 2.02 index.There was no impact to patient management reported.
Additional Manufacturer Narrative
This follow up is submitted to populate with data that had previously been provided.There is no change to the content of the data.

• 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: 11426234
• Report Number: 3016438761-2021-00082
• Device Sequence Number: 19655081
• 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): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 3M74-98
• Device Catalogue Number: 03M74-98
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1