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

Catalog Number C58957

Device Problem High Readings (2459)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/20/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported questioned high positive covid igm results (access sars-cov-2 igm, part number c58957, lot number not provided) on the customer's access 2 (access 2 immunoassay analyzer, part number 386220 and serial number (b)(4)) for 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 did inquire about whether there were any potential known interferences because of the high 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 not provided for review.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.

Manufacturer Narrative

(b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The customer did not provide reagent lot; therefore, lot number, expiration date and udi are not available.The customer did not provide reagent lot; therefore, date of manufacture is not available.The access sars-cov-2 igm assay was not returned for evaluation.There were no reports of system issues at the time of the event.No hardware errors or flags were reported in conjunction with the event.Customer inquired about potential interferents which were associated with the high results.Customer technical support (cts) advised customer of possible interferents listed in the access sars-cov-2 igm instructions for use (ifu).Cts also advised the customer that the access sars-cov-2 igm assay is intended for qualitative results (reactive or non-reactive) and not quantitative results.In conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest a malfunction.Per current cdc guidelines available on the cdc website, igm antibody can persist for weeks to months following infection.Persistence of detectable antibodies may vary by the test used.

• Brand Name: ACCESS SARS-COV-2 IGM ASSAY
• 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: 11877448
• MDR Text Key: 281413143
• Report Number: 2122870-2021-00073
• 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: health professional,user faci
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C58957
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1