MAUDE Adverse Event Report: BIOBASIC BIOBASIC SARS-COV DETECTION KIT; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem False Positive Result (1227)

Patient Problem Test Result (2695)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

The master mix for rt-pcr sars-cov-2 testing was defective causing delay in test results.Controls were ran with the test run and all resulted as false positive.After repeating at a confirmatory reference lab, the results were negative.

• Brand Name: BIOBASIC SARS-COV DETECTION KIT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): BIOBASIC ; 20 konrad crescent; markham, on L3R 8 T4; CA L3R 8T4
• MDR Report Key: 10142602
• MDR Text Key: 194943710
• Report Number: MW5094927
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other