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	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The number of patients was not specified.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 hardware errors or other assay issues were reported in conjunction with this event.The field service engineer (fse) did not find any instrument issue which may have contributed to this event.No patient clinical information (pcr, symptoms, vaccination) was provided.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.Moreover the roche assay used targets antibodies anti-nucleocapsid while the access assay detects only antibodies directed against the spike protein, which are more likely to neutralize the virus.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.In conclusion the cause of the discrepant results could not be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2021 the customer reported non reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 922628) results were generated for several patients on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4)).The number of patients was not provided.The customer reported that the non-reactive access sars-cov-2 igg results were discrepant with an alternate methodology (roche cobas's nucleocapside assay).The customer reported having done the tests also on the instrument unicel dxi 800 access immunoassay analyzer serial number (b)(4).No further information was provided.No clinical information was provided.No affect to patients or end-users has been reported in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.No calibration and no quality control (qc) was provided.A field service engineer (fse) was dispatched on (b)(6) 2021.The fse did not find any instrument issue which may have contributed to this event.There were no issues with sample integrity reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, centrifugation, storage and other sample related information was not provided by the customer.

• 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: 11619668
• Report Number: 2122870-2021-00043
• Device Sequence Number: 11586112
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210731(11)201203(10)922628
• 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): 04/06/2021

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: 07/31/2021
• Device Catalogue Number: C58961
• Device Lot Number: 922628
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1