MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 195-160

Device Problems Component Missing (2306); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

Abbott binaxnow: gtin: (b)(4), ref: 195-150, manufacture date: 2022-01-04, lot: 178298 contents label on the package did not match package contents.Content labeling states 2 nasal swabs should be included.Nasal swabs were missing from the package.Impact: none.Fda safety report id# (b)(4).

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 13358191
• MDR Text Key: 284717456
• Report Number: MW5106957
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 178298
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White