MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	195-100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Ordered biaxnow covid-19 home test from (b)(6) on (b)(6) 2021 to replace kits previously ordered in (b)(6) that were about to expire.Receive the 6 kits on 09/28/2021 and, again, kits are short dated making it impossible to use serially over time.(b)(6) refused to replace the kits.Ref: 195-100, lot: 139380, expiration: 2021-09-18 (+3 months extension).Sold by (b)(6).Fda safety report id # (b)(4).

• Brand Name: BINAXNOW COVID-19 AG CARD HOME TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12561745
• Report Number: MW5104305
• Device Sequence Number: 3596968
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: (01)00811877011330
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/28/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/18/2021
• Device Model Number: 195-100
• Device Catalogue Number: 195-100
• Device Lot Number: 138380
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1