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

Catalog Number 195-000

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported fifty-six (56) false negative results with the binaxnow covid-19 ag card between july 2021 and august 2021.The customer initially reported seven (7) false negative results that were confirmed positive with pcr and subsequently reported an additional forty-nine (49) false negative results.This is report six (6) of fifty-six (56).The customer reported a false negative result with the binaxnow covid-19 ag card.Pcr confirmation testing using thermo fisher platform was performed on (b)(6) 2021 on an oropharyngeal swab and generated positive results (ct value 23.3).Per the customer the patient was symptomatic.Although requested, additional information, including patient treatment and outcome was not provided.

Manufacturer Narrative

This investigation is still in progress.Once the investigation is complete a supplemental report will be provided.For the initial 7 false negatives, reference mfr.Reports: 1221359-2021-03769 through 1221359-2021-03774, 1221359-2021-02489.For the subsequent 49 false negatives, reference mfr.Reports: 1221359-2021-03775 through 1221359-2021-03822, 1221359-2021-03435.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 131522 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 195-000/ lot: 131522, test base part number 195-000 / lot: 131522.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 131522 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 possibly be related to the specific patient samples.Related reports: 1221359-2021-02489, 1221359-2021-03769 through 1221359-2021-03774.

• Brand Name: BINAXNOW 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: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13113860
• MDR Text Key: 283593275
• Report Number: 1221359-2021-03773
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721042610131522
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Device Lot Number: 131522
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• 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