MAUDE Adverse Event Report: ABBOTT LABORATORIES SARS-COV-2 IGG REAGENT KIT

Model Number	06R8620
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
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.Patient identifier complete entry = (b)(6), collected on (b)(6) 2020, (b)(6), collected on (b)(6) 2020, for the same patient.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false positive sars-cov-2 igg result for a white male patient, who had no covid-19 symptoms, on an architect i1000sr analyzer.The following data was provided (<1.4 index (s/c) is negative, >/=1.4 index (s/c) is positive): sample id (b)(6), collected on (b)(6) 2020, initial result was 5.9 index (s/c).Patient was recollected on (b)(6) 2020, sample id (b)(6), initial result was 6.3 index (s/c).The sample was then sent out on (b)(6) 2020, tested on (b)(6) 2020, using a diasorin liaison igg antibody test, initial result was <3.9, no units of measure were provided, results >15 are positive.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false positive architect sarscov-2 igg results, when compared to the diasorin liason assay, included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Return testing was not complete as return samples were not shipped on dry ice, per shipping requirements.Specificity testing was done using an in-house retained kit of lot 17001m800 stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Immunocompromised patients who have covid-19 may have a delayed antibody response and produce levels of antibody which may not be detected as positive by the assay.Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show either falsely elevated or depressed values when tested with assay kits such as sars-cov-2 igg that employ mouse monoclonal antibodies.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference, and anomalous values may be observed.Rheumatoid factor (rf) in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.In this case, information on the onset of symptoms and the pcr positive test were not available.Labeling was reviewed and sufficiently addresses the customer's issue.Device history record review on lot 17001m800 did not show any potential non-conformances, or deviations related to the customer observation.To assess the clinical performance of the assay, a study was performed using 122 serum and plasma specimens collected at different times from 31 subjects who tested positive for sars-cov-2 by a polymerase chain reaction (pcr) method and who also presented with covid-19 symptoms.The positive percent agreement (ppa) at >/=14 days post-symptom onset is 100.00% (95% ci: 95.89, 100.00).Five specimens from 1 immunocompromised patient were excluded from the study.When the results from these specimens were included, the ppa at >/=14 days post-symptom onset was 96.77% (95% ci: 90.86, 99.33).Additionally, review of the manuscript bryan et al.2020, "performance characteristics of the abbott architect sars-cov-2 igg assay and seroprevalence in boise, idaho", j.Clin.Microbiol, doi: 10.1128/jcm.00941-20, showed sensitivity data consistent with product labeling.125 patients who tested rt-pcr positive for sars-cov-2 for which 689 excess serum specimens were available was tested and it was found that sensitivity reached 100% at day 17 after symptom onset and day 13 after pcr positivity.Based on the investigation architect sars-cov-2 igg reagent lot 17001m800 is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igg reagent was identified.

• Brand Name: SARS-COV-2 IGG REAGENT KIT
• Common Device Name: SARS-COV-2 IGG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 10329652
• Report Number: 1415939-2020-00111
• Device Sequence Number: 19486035
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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 Expiration Date: 07/29/2020
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Device Lot Number: 17001M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1