MAUDE Adverse Event Report: INNOVA MEDICAL GROUP INNOVA SARS COV2 ANTIGEN RAPID QUALITATIVE TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number X2012005

Device Problem False Negative Result (1225)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

The patient experienced a false negative result with the innova antigen test and received a positive test result from a pcr covid test when tested with nhs.User handling may have contributed to the event.Possible contributing factors of a false negative result are: unpacked test strips have been left too long, resulting in moisture.Sample was spiked too quickly with too much sample; the sample was not diluted at the right multiple or the sample was drunk before the test.The amount of antigen in a sample may decrease as the duration of illness increases.Specimens collected after day 5 of illness are more likely to be negative compared to a rt-pcr assay.A false negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected improperly.The production records, product inspection records and material inspection records were checked confirming batch records are qualified.It is recommended that the testing kit must be operated according to the specimen collection and assay methods in the body of the instructions for use and additionally, the kit should be used immediately after opening the lid.The reported event could not be confirmed.

Event Description

It was reported by the patient false negative result was received with the innova antigen test.It was further noted the patient had received a pcr positive test result from the national health service (nhs).Additional information for product-specific information and complete complaint details was requested; however unsuccessful.The patient responded that the medical waste had been disposed of due to unreasonable contact time.It was further noted the patient had a low-level response but did expose others to the risk due to the false negative result.

• Brand Name: INNOVA SARS COV2 ANTIGEN RAPID QUALITATIVE TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): INNOVA MEDICAL GROUP; 801 e. colorado blvd.; suite 288; pasadena CA 91101
• Manufacturer (Section G): INNOVA MEDICAL GROUP; 801 e. colorado blvd.; suite 288; pasadena CA 91101
• Manufacturer Contact: douglas woodruff ; 801 e. colorado blvd.; suite 288; pasadena, CA 91101 ; 6262390025
• MDR Report Key: 13080359
• MDR Text Key: 287199942
• Report Number: 3017105091-2021-00004
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: X2012005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sex: Male