MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG (1ST IS); IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C74339

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.No "expiration date", "udi" and "device manufacture date" could be provided as no lot number was supplied.The access sars-cov-2 igg (1st is) reagent was not returned for evaluation.No hardware errors or other assay issues were reported in conjunction with this event.¿ one patient sample was sent to the (b)(4) chu for investigation.Due to the low volume available, patient sample was first tested neat for the sars-cov-2 igg (1st is) assay.The (b)(4) chu obtained a reactive sars-cov-2 igg (1st is) result.Customer's result was therefore not confirmed.¿ there have not been any studies yet comparing the access sars-cov-2-igg (1 st is) assay to any other manufacturers.¿ 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.Results obtained with the access assay may not be used interchangeably with values obtained with different manufacturers¿ test methods.¿ per the who study, ¿establishment of the who international standard reference panel for anti-sars-cov-2 antibody¿, mattiuzzo et al., variability of quantitative results with the who 1st is is evident manufacturer to manufacturer and method to method.Variation amongst quantitative results of serology assays are expected even when traceable to the same who international standard.Some factors which may contribute to variability of inter-manufacturer results are affinity of the antibodies in positive samples, assay format, and clinical decision points for the assay.Although variability amongst quantitative results is expected, qualitative result should be in alignment with the results of manufacturers who also have a who traceable igg assay.¿ there is no international consensus determining the protective antibody response for sars-cov-2.¿ the access assays is not labelled for vaccine response detection.The performance of our serology assays has not been established in individuals that have received a covid-19 vaccine.¿ depending upon the vaccine administered, the antibodies generated may be different and therefore the test result may differ depending upon the specific antibody being detected by the assay in use in the laboratory.In conclusion, the cause of the event cannot be determined with the available information.The investigation did not confirm customer's result.The patient was found reactive for sars-cov-2 igg.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

Event Description

On 16aug2021 the customer reported one non-reactive sars-cov-2 igg 1st is (access sars-cov-2 igg 1st is assay, part number c74339, lot number not provided) result was generated for one vaccinated patient on the customer's unicel dxi 800 access immuno analyzer (part number 973100 and serial number (b)(4)).The customer reported that the non-reactive access sars-cov-2 igg 1st is patient result was discordant with the roche method.No data was provided by the customer.The customer also reported that the patient sample was tested with the access sars-cov-2 igg ii assay with non-reactive result.Per customer verbal 's report the patient was vaccinated with the pfizer vaccine and had received his second dose on (b)(6) 2021.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 system check, calibration and quality control (qc) data was provided.One patient sample was sent to the (b)(4) complaint handling unit (chu) for investigation.Due to the low volume available, patient sample was first tested neat for the sars-cov-2 igg (1st is) assay.The (b)(4) chu obtained a reactive sars-cov-2 igg (1st is) result.Customer's result was therefore not confirmed.There were no issues with sample integrity reported by the customer.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.Two (2) medwatch reports will be generated to address the non-reactive sars-cov-2 igg ii and the sars-cov-2 igg 1st is patient results: medwatch number ¿2122870-2021-00147¿ will address the non-reactive sars-cov-2 igg ii patient result.Medwatch number ¿2122870-2021-00148¿ will address the non-reactive sars-cov-2 igg 1st is patient result.

Manufacturer Narrative

This event is part of field action fa-21047.

• Brand Name: ACCESS SARS-COV-2 IGG (1ST IS)
• 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: 12473660
• MDR Text Key: 283607464
• Report Number: 2122870-2021-00148
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C74339
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/16/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2508-2021
• Patient Sequence Number: 1