MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2-IGG ASSAY; REAGENT, CORONAVIRUS SEROLOGICAL

Model Number 06R8620

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

The customer observed discrepant architect sars cov-2 igg results when performing a lot-to-lot comparison.The customer stated 17 samples were run over the course of 3 days, however only had 5 samples to provide.The reference range: < 1.40 s/co is negative, >/= 1.40 s/co is positive.Sample #1: 0.51 s/co (previous lot) / 0.29 s/co (new lot) sample #2: 1.84 s/co (previous lot) / 0.90 s/co (new lot) sample #3: 15.65 s/co (previous lot) / 9.06 s/co (new lot) sample #4: 2.46 s/co (previous lot) / 1.62 s/co (new lot) sample #5: 0.04 s/co (previous lot) / 0.02 s/co (new lot) the customer believes that the results generated from the new reagent lot are questionable.One sample (sample #2) out of the 5 samples provided was false negative for sars cov-2 igg.The other 4 samples were reviewed and do not meet reportability criteria.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely depressed architect sars-cov-2 igg results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search for lot 40132fn00 and a sublot 40132fn search with did not identify an increase in complaint activity related to falsely depressed results.Tracking and trending data were reviewed and did not identify any related trends.Clinical sensitivity and clinical specificity testing were performed using an in-house retain kit of complaint lot 40132fn00.All specifications were met indicating the lot is performing acceptably.The device history record review was performed on lot 40132fn00, which did not show any potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to adequately address the issue of falsely depressed results the customer's issue.Based on the investigation, no systemic issue or product deficiency for architect sars-cov-2 igg reagent lot 40132fn00 was identified.

• Brand Name: SARS-COV-2-IGG ASSAY
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15386962
• MDR Text Key: 300154481
• Report Number: 3008344661-2022-00104
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Device Lot Number: 40132FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)