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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.Customer did not provide a reagent lot number; therefore, lot number, expiration date and udi information are unavailable.(b)(6).Customer did not provide a lot number; therefore, date of manufacture is not available.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 calibration and quality control results were not provided for review.No issues with sample integrity were reported by the customer.Applications technical support reviewed customer workflow and advised on avenues to prevent contamination, such as cleaning pipettes after each use via manufacturer instructions, not storing polypropylene tubes on the bench, but in small sealed containers, and to allow the extraction solution to come to room temp for at least 30 minutes prior to use.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, lot number not provided) were generated on the customer's dxi (unicel dxi 600 access immunoassay analyzer, part number a30260 and serial number (b)(4)).The customer reported a total of eight (8) patients samples were reactive with the beckman covid antigen test while results with the cepheid method (pcr) were non-reactive.The customer supplied data for five (5) of the eight questioned samples.See next section for test results.The customer did not indicate whether the results were reported out of the laboratory.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 calibration and quality control 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 quality, storage temperature and other information was not provided by the customer.

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: 11738441
• MDR Text Key: 280876586
• Report Number: 9680746-2021-00033
• 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
• 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: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C68668
• 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