MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-000

Device Problem False Negative Result (1225)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The customer reported an unknown quantity of false negative results with the binaxnow covid-19 ag card performed on unknown dates.The customer stated that coworkers at her facility performed tests (brand unknown) at home on unknown dates and generated a positive result.There was no indication of false patient results.Although requested, no additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

B3: the date indicated is an approximation as the exact event date was not provided.The customer was concerned that their reagent solution may be expired but did not provide the lot number for confirmation.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 unknown quantity of false negative results with the binaxnow covid-19 ag card performed on unknown dates.The customer stated that coworkers at her facility performed tests (brand unknown) at home on unknown dates and generated a positive result.There was no indication of false patient results.Although requested, no additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

B3: the date indicated is an approximation as the exact event date was not provided.The customer was concerned that their reagent solution may be expired but did not provide the lot number for confirmation.The intake information required to enable further investigation, such as the kit¿s lot number, were not provided and an investigation was not able to be performed.Notwithstanding, complaints against these customer experience codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• 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: 18731410
• MDR Text Key: 335815357
• Report Number: 1221359-2024-00196
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/04/2024
• 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