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

Catalog Number	C58961
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 21jun2021 the customer reported non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 922776) results for five patients were generated on the customer's remanufactured dxi immunoassay analyzer (part number a25288 and serial number (b)(4)).The customer reported obtaining positive results in an alternate laboratory (no further information was provided regarding the methodology used at alternate site).Per customer verbal's report, patients 2-5 from the data table below (refer to the "relevant tests/laboratory data" ) had a history of covid infection.None of the patients were reported to be vaccinated against covid-19.No historical clinical information was available for patient 1.No affect to patients or end-users has been reported in connection with this event.No error messages or issues with other assays were reported.There were no reports of hardware interventions performed or hardware parts replaced.Cov2g calibration passed on 07jun2021 using reagent lot 922776 and calibrator lot 922849.Qc was passing within the laboratory¿s established ranges.No issues with sample integrity were reported by the customer.The local support organization explained differences between assays targeting nucleoprotein and assays targeting spike protein.Two (2) medwatch reports will be generated to address customer reports of non-reactive sars-cov-2 igg patients results obtained at two different dates.Medwatch number ¿2122870-2021-00099¿ will address patient four (4) result obtained on (b)(6) 2021.Medwatch number ¿2122870-2021-00100¿ will address patients 1-3 and 5 results obtained on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(6) the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igg reagent was not returned for evaluation.No error messages or issues with other assays were reported.Available system performance indicators of passing calibration and quality control recovery did not demonstrate an issue with the system.There were no reports of hardware interventions performed or hardware parts replaced.¿ 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.¿the local support organization explained differences between assays targeting nucleoprotein and assays targeting spike protein.¿values obtained with different assay methods should not be used interchangeably and differences between methods are expected.In conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a reagent or hardware malfunction occurred in this event.

• Brand Name: ACCESS SARS-COV-2 IGG
• 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: 12129177
• Report Number: 2122870-2021-00100
• Device Sequence Number: 3624753
• 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): 07/07/2021

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
• Distributor Facility Aware Date: 06/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1