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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW STREP PNEUMONIAE 22T (LFR); ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW STREP PNEUMONIAE 22T (LFR); ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. Back to Search Results
Catalog Number 710-100
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2023
Event Type  malfunction  
Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.This report is being filed on an international product, list number 710-100 that has a similar product distributed in the us, list number 710-000.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
 
Event Description
The customer reported an unspecified number of false negative results with the binaxnow streptococcus pneumoniae antigen card performed on or before (b)(6) 2023 on an unknown sample type.Additional testing was performed via a biofire test (platform: unknown) on an unknown date which generated a positive result.No additional patient information, including treatment and outcome, was provided.
 
Event Description
The customer reported an unspecified number of false negative results with the binaxnow streptococcus pneumoniae antigen card performed on or before (b)(6) 2023 on an unknown sample type.Additional testing was performed via a biofire test (platform: unknown) on an unknown date which generated a positive result.No additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
Additional information received: d1 - brand name has changed to binaxnow strep pneumoniae 22t d4 - catalog # has changed to 710-000 b3: the date provided is an approximation as the exact event date was not provided.D4-udi:((b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 184259 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 710-000/ lot: 184259, test base part number 710-430 / lot: 192976.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 184259 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to the specific patient sample or the customer performing the testing procedure incorrectly.D2b:procode changed to gtz d4:udi added in h10.
 
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Brand Name
BINAXNOW STREP PNEUMONIAE 22T (LFR)
Type of Device
ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key18487402
MDR Text Key332727056
Report Number1221359-2024-00049
Device Sequence Number1
Product Code GTC
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/02/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/10/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2023
Device Catalogue Number710-100
Device Lot Number184259
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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