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

Catalog Number C69057

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity or race.The access sars-cov-2 igg ii assay was not returned for evaluation.There were no reports of system issues at the time of the event.There was no report of issues with other assays at the time of the event.No hardware errors or flags were reported in conjunction with the event.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported that questioned erratic covid igg results (access sars-cov-2 igg ii, part number c69057, lot number 124558) was generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)) on (b)(6) 2021 for two patients.The initial results were released from the laboratory.The customer did not report a change to patient care of treatment in connection with this event.The patients were redrawn the next day and results which were discordant to the original results were obtained.The customer then questioned the original results.The customer then retested the original samples and obtained different results.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 passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.Samples were collected and initially tested in lithium heparin gel tubes; and repeat testing was performed using frozen/thawed aliquots of these samples.Samples were centrifuged for 5 minutes at room temperature (centrifugation speed not provided).

• Brand Name: ACCESS SARS-COV-2 IGG II
• 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: 12641506
• MDR Text Key: 281922521
• Report Number: 2122870-2021-00167
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590742744
• UDI-Public: (01)15099590742744(17)211031(11)210503(10)124558
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: C69057
• Device Lot Number: 124558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1