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 False Negative Result (1225)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported non-reactive covid igg results (access sars-cov-2 igg (1st is), part number c74339 and lot number 124466) were generated on the customer's dxi (unicel dxi 600 access analyzer, part number a30260 and serial number (b)(4)) for one patient.The original result was non-reactive at 24.17 iu/ml and the repeated result was non-reactive at 22.37 iu/ml.The customer did not indicate whether the results were released from the laboratory.The customer did not report a change to patient care of treatment in connection with this event.The customer reported the patient sample had generated reactive results with the abbott anti sars-cov-2-igg -s1/rbd method and the chorus for iga, igg and igm detection assay methods.The abbott result was 40.1 bau who/ml (a reactive result is =7.1 bau who/ml).The chorus result was 232.5 (no unit provided).The customer reported that the patient had been ill at the end of (b)(6), and a negative pcr result was obtained in (b)(6) (no data provided).No hardware errors were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, sample quality, centrifugation time and speed, storage temperature and other information was not provided by the customer.

Manufacturer Narrative

(b)(6).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access sars-cov-2 igg (1st is) assay was not returned for evaluation.There were no reports of system issues at the time of the event.All assay and system verifications met specifications at the time of the event.No hardware errors or flags were reported in conjunction with the event.One patient sample was sent to the beckman coulter complaint handling unit (chu) for investigation.The patient sample was tested neat with the sars-cov-2 igg (1st is) assay.The chu obtained one non-reactive result close to the results obtained by the customer.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.No manufacturer guarantees both a specificity and sensitivity of 100%.The concentration of sars-cov-2 igg in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, diversity of antibodies and reagent specificity.Differences in each individual assay are expected.In conclusion, the cause of this event cannot be determined with the available information.

Manufacturer Narrative

This event is part of field action (b)(4).

• 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
• MDR Report Key: 12050924
• MDR Text Key: 281591302
• Report Number: 2122870-2021-00090
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590746919
• UDI-Public: (01)15099590746919(17)210930(11)210402(10)124466
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: C74339
• Device Lot Number: 124466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2508-2021
• Patient Sequence Number: 1