MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem False Positive Result (1227)

Patient Problem Cough (4457)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported false positive result with the binax now covid-19 antigen self test performed on (b)(6) 2021.The customer stated that the control side was a pink line and no pink line on sample side, and the test results read an (1) hour later then the customer see's a faint pink line on the sample side.As per the customer two (2) test was performed on the binaxnow covid-19 ag and generated negative results.Pcr confirmation testing was performed and generated negative result.The customer stated patient was symptomatic with a cough and had taken ibuprofen.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

B5: correction report.It was initially reported that the consumer read the results from the binaxnow covid-19 ag antigen self test which indicated a negative result by showing a pink line on the control and no line on the sample.Consumer then reported after reading the results approximately one hour later, there was a faint pink line on the sample.Upon further review, this event should not have been reported as this is user error with no medical intervention or harm as a result.The product insert for binaxnow covid-19 ag antigen self test indicates that the results are to be read between the fifteen and thirty minute mark and that any results read outside of that timeframe should not be considered valid.

• Brand Name: BINAX NOW COVID-19 HOME TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: naissa bogard ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12285289
• MDR Text Key: 265627374
• Report Number: 1221359-2021-02219
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722120110152841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 152841
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White