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

Catalog Number	C58961
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full identifier is case (b)(6).The customer did not provide patient demographics such as weight, ethnicity or race.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 abbott alinity assay also detects antibodies directed against the spike protein.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.It is unknown which roche assay (anti-spike versus anti-nucleoprotein) was used.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2021 the customer reported negative covid igg results (access sars-cov-2 igg, part number c58961 and lot number 922776) were generated on the customer's dxi (unicel dxi 800 access analyzer, part number 973100 and serial number (b)(4)) for an two samples from one patient.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 two different sars-cov-2 assays: the roche sars-cov-2 ab assay and the abbott alinity sars-cov-2 igg assay.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
• Common Device Name: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11630891
• Report Number: 2122870-2021-00044
• Device Sequence Number: 3262882
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210831(11)210103(10)922776
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: 08/31/2021
• Device Catalogue Number: C58961
• Device Lot Number: 922776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR