MAUDE Adverse Event Report: GENABIO DIAGNOSTICS INC GENABIO; GENABIO COVID-19 RAPID SELF TEST

Model Number RA9-E00302

Device Problem Material Discolored (1170)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2022, a customer called regarding a defect with our product "genabio covid-19 rapid self-test kit".The user reported browning or dirt like substance on the sealed nasal swab.The user did not use the product after discovering this issue.The user provided us with the lot number of the product and emailed our support address with images of the defect.We did not receive the original product for investigation.As part of our complaint investigation, an additional investigation was conducted on items remaining in inventory from the affected lot.No nasal swabs with similar defective qualities as reported were found.We will continue to closely monitor this for any similar quality issues.It is concluded that this was an isolated incident, as analysis of previous complaints result in no trend of similar issues.Sponge swabs will generate colored azo compounds due to light, heat or oxidants, which may cause discoloration of sampling swabs.On the production line, we generally reject this kind of swab when we see it, but very few times it will be missed.It is believed that this incident is a result of discoloration due to azo compounds due to light, head or oxidants, not a bacterial contamination.This could be a result of a missed quality inspection during manufacturing.We will continue to monitor for this type of complaint and our contracted manufacturer and quality services were contacted.

Event Description

On (b)(6) 2022, a genabio diagnostics customer submitted a complaint via email indicating that they opened up one of the genabio covid tests and discovered that the swab was used and covered with brown stains.They called our company to report this on the same day.The lot number provided by the customer was us220925.A picture of the swab was provided by the customer (see attachment).On 16-dec-2022 the fda informed genabio diagnostics that the issue had been reported to them on medwatch report number mw5113786.

• Brand Name: GENABIO
• Type of Device: GENABIO COVID-19 RAPID SELF TEST
• Manufacturer (Section D): GENABIO DIAGNOSTICS INC; 19b crosby dr; ste 220; bedford MA 01730
• Manufacturer (Section G): HANGZHOU LAIHE BIOTECH CO.,LTD; no.688 bin'an road, changhe st; room 505 - 512, 2b building; binjiang district,hangzhou,, zhejiang 31005 2; CH 310052
• Manufacturer Contact: jia he ; 19b crosby dr; ste220; bedford, MA 01730
• MDR Report Key: 16103832
• MDR Text Key: 308649679
• Report Number: 3016609999-2023-00001
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00196852953004
• UDI-Public: 00196852953004
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 03/16/2024
• Device Model Number: RA9-E00302
• Device Lot Number: US220925
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1