MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 195-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported the patient had an allergic reaction after doing the sars-cov-2 nucleocapsid to enter an er facility.Per the customer, this incident was related to an abbott id swab test.However, the binaxnow covid-19 positive control contains non-infectious recombinant sars-cov-2 nucleocapsid antigen dried onto a swab.The patient came in for allergic reaction to fluconazole yeast medication.Reported confusion and sharp head pains prior to entering the facility on (b)(6).Per the customer, the patient experienced the following reactions: brain pains, night sweats, closing of throat and trouble breathing.Also, lack of comprehension and tiredness which began for about 2-3 weeks after the (b)(6) visit.The patient was provided basic treatment and advised to follow up with a general practioner.Suggested help was to quit fluconazole medication, liquids, and to rest.The positive control swabs are made with non-infectious recombinant sars-cov-2 nucleoplasmic antigen dried onto a swab and a sterile patient swab provided in the kit is used as the negative control swab.Control swabs have no risk of infection or serious harm and the event would be considered not reportable.Per medical opinion: the complaint report stated that the primary reason for the patient's visit to the er was for a possible allergic reaction to fluconazole (an anti-fungal medication).Common side effects of this medication can include similarities with some of the symptoms that this patient experienced, such as headache, shortness of breath, dizziness.If the primary reason for the er is confirmed to be due to a reaction to fluconazole, as was described in the complaint file, then that is most likely the cause of his symptoms, rather than an allergic response to a swab.However, out of an abundance of caution, it is still reasonable to report as an adverse event.Additional information has not been provided regarding the event.

Manufacturer Narrative

Additional information: the reaction was with the longer sterile "patient swab" in (b)(6) 2020.The patient has had continued head pains and gradual development of ringing in the ears.

Manufacturer Narrative

The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.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: BINAXNOW COVID-19
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• 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: 11606665
• MDR Text Key: 244857988
• Report Number: 1221359-2021-00871
• Device Sequence Number: 1
• Product Code: QKP
• 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,Followup
• Report Date: 04/20/2022

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?: No
• Device Catalogue Number: 195-000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 03/28/2022
• Supplement Dates FDA Received: 07/01/2021; 04/20/2022
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 65 KG