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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF-TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF-TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problems False Negative Result (1225); False Positive Result (1227)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Event Description
The customer reported four (4) false negative results with the id now covid-19 assay performed between (b)(6) 2022 and (b)(6) 2022, with one test being taken on (b)(6) 2022 after the pcr test was performed.This report is tests three (3) of four (4).Pcr testing was performed on (b)(6) 2022 and generated a positive result.No additional information regarding outcome was provided.
 
Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Please refer to related mfr report numbers: 1221359-2022-03185, 1221359-2022-03188.
 
Event Description
Correction: false negative results was with the binaxnow covid-19 antigen self test not id now covid-19.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 186666 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 195-160/ lot 186666 and device part number 195-430h/ lot 173829.The lot met the required release specifications.The current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4)%.In conclusion, 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.Substances in the sample itself may have interfered with the reaction.Please refer to related mfr report numbers: 1221359-2022-03185, 1221359-2022-03188 through 1221359-2022-03190.
 
Manufacturer Narrative
This report is being submitted to correct the h6 "medical device problem code" listed in the intial report.Please see h6 of this report for the corrected code.
 
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Brand Name
BINAXNOW COVID-19 ANTIGEN SELF-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
rachel blackwell
10 southgate road
scarborough,
MDR Report Key14830345
MDR Text Key301639021
Report Number1221359-2022-03190
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081723031610186666
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number195-160
Device Lot Number186666
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2022
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 Number1
Patient SexFemale
Patient Weight91 KG
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