MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS SARS-COV-2 ANTIGEN; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C68668

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The full identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 antigen 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.System performance indicators such as system check and calibration passing within specifications.No issues with sample integrity were reported by the customer.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported reactive beckman covid antigen patient results (access sars-cov-2 antigen, part number c68668 and lot number 971260) were generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)).The customer reported a total of two (2) patients samples were reactive with the beckman covid antigen test while results with the biofire respiratory panel 2.1 (pcr methodology) were non-reactive.The customer indicated the results were reported out of the laboratory but were questioned by the physician.The customer did not report a change to patient care of treatment in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check and calibration were passing within specifications at the time of the event.Although it was noted that the quality control (qc) level 2 had a "qcf" (qc fail) flag, there is insufficient information to reasonably suggest a use error or reagent malfunction was the cause of the qc failure.No issues with sample integrity were reported by the customer.The customer reported remel microtest tubes were used for transport media.The customer reported mantacctm flocked swabs used by miraclean technology are used for specimens.No issues were reported with the swabs.

Manufacturer Narrative

Bec tracking number: (b)(4).

• Brand Name: ACCESS SARS-COV-2 ANTIGEN
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 11873992
• MDR Text Key: 252352782
• Report Number: 9680746-2021-00039
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590742713
• UDI-Public: (01)15099590742713(17)210608(11)201210(10)971260
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

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 Expiration Date: 06/08/2021
• Device Catalogue Number: C68668
• Device Lot Number: 971260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2255-2021
• Patient Sequence Number: 1