MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG ASSAY; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C58961

Device Problem False Negative Result (1225)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

The full identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity or race.The customer telephone number is (b)(6).The access sars-cov-2 igg 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.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.Both the access and roche assays detect antibodies directed against the spike protein, which are more likely to neutralize the virus.The roche assay is a total assay, detecting igg, igm and iga without distinction.The results of a total assay cannot be compared to the results of an ¿igg-only¿ assay.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.Different vaccines do not elicit the same immune response and each patient response is different therefore differences in patient responses are expected after vaccination.The access assay is not labeled for vaccine response detection.In conclusion, while the access assay is not labeled for vaccine response detection, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported non-reactive covid igg results (access sars-cov-2 igg, part number c58961 and lot number 922628) were generated on the customer's dxi (unicel dxi 800 access analyzer, part number 973100 and serial number (b)(4)) on (b)(6) 2021 for one patient sample.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 roche elecsys anti-sars-cov-2 s assay.The customer reported that the patient was laboratory technicians had received the first of two doses of the astra-zeneca vaccine 55 days prior to testing.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.

• Brand Name: ACCESS SARS-COV-2 IGG ASSAY
• 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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11724608
• MDR Text Key: 272281898
• Report Number: 2122870-2021-00052
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210731(11)201203(10)922628
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: C58961
• Device Lot Number: 922628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2021
• Date Device Manufactured: 12/03/2020
• 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