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

Catalog Number C58957

Device Problem Erratic Results (4059)

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

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

Full patient identifier is case- (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 a access sars-cov-2 igm assay lot number; therefore, the date of manufacture and the udi could not be determined.The customer did not provide a access sars-cov-2 igm assay lot number; therefore, the date of expiration could not be determined.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.There were also no reports of issues with other assays at the time of the event.The fse dispatched to the site reported a failing system check; however, date of failing system check was not provided.Fse reported cleaning or replacing several components; fse did not identify any specific component as causative of the event.In conclusion, although the fse serviced the instrument, there is insufficient information available to suggest a malfunction.

Event Description

On (b)(6) 2020 the customer reported that positive results were generated on the customer's access 2 immunoassay analyzer (access) (part number 386220 and serial number (b)(4)) for the sars-cov-2 igm (access sars-cov-2 igm, part number c58957).The samples were repeat tested on the customer's dxi (instrument part number and serial not provided) and results obtained from the dxi were negative.Customer did not provide patient results for review.Customer did not indicate whether correct results were positive or negative.There was no report of change to patient treatment or management in connection with the event.No hardware errors or other assay issues were reported in conjunction with the event.The customer did not provide system performance indicators such as calibrations or quality control (qc) data for review.No issues with sample integrity were reported by the customer.Sample collection and handling information such as sample type, collection tube type and manufacturer, clot time (if applicable), centrifugation time, speed and temperature were not provided by the customer.A field service engineer (fse) (local support) was dispatched to the site to assess instrument performance.Fse noted failed system check (system check date not provided).

• Brand Name: ACCESS SARS-COV-2 IGM
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11066988
• MDR Text Key: 240318095
• Report Number: 2122870-2020-00098
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1