MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW RSV WAIVED 22T; ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Catalog Number 430-122

Device Problem False Negative Result (1225)

Patient Problem Respiratory Arrest (4461)

Event Date 01/01/2024

Event Type  Injury  

Event Description

The customer reported a false negative result with the binaxnow rsv test on an unknown date with an unknown sample type.Per the customer, prior to initial testing, the patient was "really sick." following the false result and patient's subsequent departure, the patient stopped breathing and was sent to a different hospital where the patient tested positive for rsv on an unknown platform.The patient was reported to be on a ventilator as of 05jan2024.Although requested, no further information including treatment and outcome was provided.No additional information including treatment and outcome was provided.Attempts to obtain this information are ongoing.

Manufacturer Narrative

Fda udi - (b)(4).The date indicated is an approximation as the exact event date was not provided.Per medical opinion, it is unclear what contribution of the alleged false negative contributed to the hospitalization/ventilation life-threatening (there is no specific rsv treatment).There was no indication that the negative result contributed to patient hospitalization and ventilation (patient was very sick before testing and the treatment of rsv are mostly symptom relieving).This event is being reported out of an abundance of caution.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported a false negative result with the binax now rsv test on an unknown date with an unknown sample type.Per the customer, prior to initial testing, the patient was "really sick." following the false result and patient's subsequent departure, the patient stopped breathing and was sent to a different hospital where the patient tested positive for rsv on an unknown platform.The patient was reported to be on a ventilator as of 05jan2024.Although requested, no further information including treatment and outcome was provided.No additional information including treatment and outcome was provided.Attempts to obtain this information are ongoing.

Manufacturer Narrative

Fda udi - (b)(4).B3: the date indicated is an approximation as the exact event date was not provided.Per medical opinion, it is unclear what contribution of the alleged false negative contributed to the hospitalization/ventilation life-threatening (there is no specific rsv treatment).There was no indication that the negative result contributed to patient hospitalization and ventilation (patient was very sick before testing and the treatment of rsv are mostly symptom relieving).This event is being reported out of an abundance of caution.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 777906w 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 430-122/ lot 777906w and test base part number 430-430 / lot 774019.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 777906w showed that the complaint rate is (b)(4)%.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.

• Brand Name: BINAXNOW RSV WAIVED 22T
• Type of Device: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• 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: 18615655
• MDR Text Key: 334221285
• Report Number: 1221359-2024-00124
• Device Sequence Number: 1
• Product Code: GQG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032166
• 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: 02/21/2024

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: 430-122
• Device Lot Number: 777906W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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
• Patient Outcome(s): Life Threatening; Required Intervention