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 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.Customer did not provide a lot number; therefore, expiration date and udi cannot be provided.(b)(6).Customer did not provide a lot number; therefore, date of manufacture cannot be provided.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.The roche assay, the abbott assay and the beckman coulter assay all detect antibodies directed against the spike protein, which are more likely to neutralize the virus.The roche assay is a total assay which detects igm, igg and iga without distinction.The results of a total assay cannot be compared to the results of an igg-only assay.The access sars-cov-2 igg assay is not labeled for vaccine response detection; assay performance has not been established in individuals who have received a covid-19 vaccine.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported negative covid igg results (access sars-cov-2 igg, part number c58961, lot number not provided) were generated on the customer's dxi (unicel dxi 800 access analyzer, part number 973100 and serial number (b)(4)) for an unknown number of patients who had positive covid igg results from two alternate platforms (abbott sars-cov-2 igg and roche sars-cov-2 ab).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 indicated some samples were collected for post vaccine monitoring; however, the customer did not provide additional information specifying which samples these were.The customer also did not indicate which vaccine(s) used for each patient/ sample.No hardware errors were reported in conjunction with this event.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were not provided for review.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
• MDR Report Key: 11760788
• MDR Text Key: 280711064
• Report Number: 2122870-2021-00060
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C58961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1