MAUDE Adverse Event Report: APPLIED BIOCODE, INC BIOCODE SARS-COV-2 ASSAY KIT

Model Number COV-2.1

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted applied biocode with a request to review results for evidence of possible carryover.Three runs conducted between (b)(6) 2020 had a higher than anticipated amount of positive results for sars-cov-2 assay testing.The runs were performed using the same lots of reagents.Run data was reviewed, no patterns were detected that pointed to possible carryover on the biocode mdx system.The king fisher extraction method that is being used at this facility is not one that is referenced in our instructions for use.The customer has also reported that new technicians are performing the testing and that some sets of samples may be pooled for testing, pre-analytical error is a possible source of the elevated positivity rate for these runs.Although there is no report of an adverse event or direct evidence of an applied biocode device malfunction we are making this report out of an abundance of caution.Correction of manufacturer report number provided 04/20/2021.

Event Description

End user had 3 runs that have high covid positivity, they repeated the three runs and the positivity rate was much lower.The original and repeat were separate extractions on the king fisher extraction system.The repeat was fresh extraction from the original sample.Run (b)(4) had 59 positive patient samples (s/n (b)(4)), the repeat (b)(4) had 6 positive patient samples (s/n (b)(4)).Run (b)(4) had 54 positive patient samples (s/n (b)(4)), the repeat (b)(4) had 14 positive patient samples ((b)(4)).Run (b)(4) had 23 positive patient samples (s/n (b)(4)), the repeat was repeated by another method and customer did not provide repeat information.The first results were not reported to the ordering physician, only the repeat run was reported to the ordering physician.There does not appear to be a pattern on the plate that would indicate in instrument issue, and plates were run on different instruments.

• Brand Name: BIOCODE SARS-COV-2 ASSAY KIT
• Type of Device: SARS-COV-2 ASSAY
• Manufacturer (Section D): APPLIED BIOCODE, INC; 12130 mora drive, unit 2; santa fe springs CA 90670
• Manufacturer (Section G): APPLIED BIOCODE; 12130 mora dr., unit 2; santa fe springs CA 90670
• Manufacturer Contact: tara viviani ; 12130 mora dr., unit 2; santa fe springs, CA 90670 ; 5627779800
• MDR Report Key: 11694161
• MDR Text Key: 248901398
• Report Number: 3007799234-2020-00001
• Device Sequence Number: 1
• Product Code: OCC
• UDI-Device Identifier: 851034007080
• UDI-Public: (01)851034007080(10)AK-07002(11)200714(17)220331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA200433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: COV-2.1
• Device Catalogue Number: 64-C0304
• Device Lot Number: AK-07002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1