MAUDE Adverse Event Report: ROCHE DIAGNOSTICS INTERNATIONAL LTD. COVID-19 AT HOME TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

When i opened package 2 (roche diagnostics), two of the tubes were open with the liquid spilled inside the pouch.Two of the four tests were usable.Fda safety report id # (b)(4).

• Brand Name: COVID-19 AT HOME TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ROCHE DIAGNOSTICS INTERNATIONAL LTD.
• MDR Report Key: 15362500
• MDR Text Key: 299371672
• Report Number: MW5111860
• Device Sequence Number: 1
• Product Code: QJR
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/13/2022
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic