MAUDE Adverse Event Report: GENABIO DIAGNOSTICS INC. COVID RAPID TESTING; COVID-19 MULTI-ANALYTE ANTIGEN DEVICE

Lot Number US220925

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

I opened a corona virus test and touched an open swab with the brown fecal-looking matter on it.I contacted the company with lot number.Date of use: (b)(6) 2022.

• Brand Name: COVID RAPID TESTING
• Type of Device: COVID-19 MULTI-ANALYTE ANTIGEN DEVICE
• Manufacturer (Section D): GENABIO DIAGNOSTICS INC.
• MDR Report Key: 15986909
• MDR Text Key: 305528030
• Report Number: MW5113786
• Device Sequence Number: 1
• Product Code: QMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/05/2022
• Device Lot Number: US220925
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Patient Sequence Number: 1
• Treatment: MULTIVITAMINS
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American