MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG (1ST IS); IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C74339

Device Problem Erratic Results (4059)

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

Event Date 05/27/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 the customer reported questioned reactive sars-cov-2 igg (1st is) (access sars-cov-2 igg (1st is) assay, part number c74339, lot number 125389) results were generated for one vaccinated patient on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4).The patient is vaccinated (no date provided, unknown vaccine).The customer reported that the patient pcr test was negative.On (b)(6) 2022, the sars-cov-2 igg 1st is patient result was positive at 87.21 au/ml, a previous result was also positive but higher at 155.36 au/ml on (b)(6) 2022.The customer questioned the positive erratic results.The patient samples were also tested with the sars-cov-2 igm assay at the same dates with discordant results.A second medwatch report will be generated to address the sars-cov-2 igm results.The patient is cmv igg and igm positive and ebv igg positive and ebv igm negative at same dates (b)(6), the customer suspected cross reactivity.There was no report of an injury or illness to the patient attributable to the output.From the device in this event.No hardware errors or issues with other assays were reported in conjunction with this event.System check passed on (b)(6) 2022.No qc data provided.Sars cov2 igg 1st is calibration passed on 9mar2022 with reagent lot 125389 and calibrator lot 125513.There were no issues with sample integrity reported by the customer.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.

Manufacturer Narrative

The fill patient identifier is (b)(6).Device evaluated by mfr: the access sars-cov-2 igg 1st is reagent was not returned for evaluation.No hardware issues were reported in conjunction with this event.Sars-cov-2 is an enveloped non-segmented positive-sense rna virus.It has several structural proteins including spike (s), envelope (e), membrane (m) and nucleocapsid (n).The spike protein (s) contains a receptor binding domain (rbd) which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ace2).It is found that the rbd of the sars-cov-2 s protein strongly interacts with the human ace2 receptor leading to endocytosis into the host cells and viral replication.The access assay detect antibodies directed against the spike protein, which are more likely to neutralize the virus.In addition, the access sars-cov-2 igg 1st is assay is not currently intended for the detection of the vaccine response.The performance of the access sars-cov-2 igg 1st is assay has not been established in individuals who have received a covid-19 vaccine.While a positive antibody test result can be used to help identify people who may have had a previous infection with sars-cov-2, more research is needed in people who have received a covid-19 vaccination.Generally, all immune responses are different, therefore differences in patient responses are expected after vaccination.Depending on the vaccine administered, the antibodies generated may be different and therefore the test result may differ depending on the specific antibody detected by the test used in the laboratory.Per the sars cov-2 igg 1st is assay instructions for use, on the ¿cross reactivity¿ section, seven reactive samples for cytomegalovirus (cmv) igg were evaluated, no cross reactivity was demonstrated ; and "five samples reactive for epstein-ber virus (ebv) igg were evaluated and no cross reactivity was demonstrated." in conclusion, a cause for this event cannot be determined with the information supplied.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• Brand Name: ACCESS SARS-COV-2 IGG (1ST IS)
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 14753170
• MDR Text Key: 295959941
• Report Number: 2122870-2022-00027
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590746919
• UDI-Public: (01)15099590746919(17)220531(11)211201(10)125389
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: C74339
• Device Lot Number: 125389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/31/2022
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 43 YR