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

Catalog Number 195160

Device Problem False Negative Result (1225)

Patient Problem Epistaxis (4458)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The consumer reported that on (b)(6) 2021, after taking a nasal sample from their son to administer the binaxnow¿ covid-19 antigen self test blood appeared.The consumer reported that the bleeding was most likely caused by the swab being inserted a bit too far.The consumer reported that the swab was red.The consumer then inquired if the control line was meant to stay blue because the user's had yet to change.Technical services informed the user that before testing she would need to make sure a blue control line is always present and then after testing the blue control line is meant to change to pink after the 15 minutes.Also, that the results should only be read between the instructed 15-30 minutes; not before or after.In this case, technical service suggested that the user not to take the results into consideration and a second kit would need to be purchased so her son could later on have the two test cards required.Technical services informed the consumer that once her son was treated for his nose bleed and he felt better he could then try to retest again.The customer agreed to take her son to his doctor to treat his nose bleed.No additional information, including treatment and outcome, was provided.

Manufacturer Narrative

Investigation: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1032793 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 190-000 / lot 1032793 and test base part number 190-430 / lot 1032793.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1032793 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.

Manufacturer Narrative

A product deficiency was not reported or identified.Based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAX NOW COVID-19 AG CARD
• 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12322096
• MDR Text Key: 266629600
• Report Number: 1221359-2021-02267
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 195160
• Device Lot Number: 153354
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 04/20/2022
• Supplement Dates FDA Received: 11/27/2021; 05/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male