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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-000
Device Problem Use of Device Problem (1670)
Patient Problems Blurred Vision (2137); Eye Burn (2523)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
A product deficiency was not reported or found. The customer was provided with the reagent safety data sheet (sds).
 
Event Description
The customer reported that a nurse in the department accidently put the binaxnow covid-19 reagent in both eyes while driving, instead of grabbing the allergy eye drops from her purse. Per the nurse she believes she inadvertently "threw" the reagent bottle in her purse instead of the garbage thinking it was her allergy eye drops as she had just opened another box of test kits. The customer reported that the nurse immediately flushed her eyes with a water bottle she had in the car. This was prior to calling for assistance. The nurse reported blurry vision and being unable to see anything. The nurse was evaluated by an opthomologist and was found to have chemical burns in both eyes. As treatment an amoeba membrane was placed on the nurse's eye and steroid/antibiotic drops were prescribed. A follow up appointment was scheduled for the next day with the opthomologist to remove the amoeba membrane and place it on the second eye. The nurse was noted to have a milky film over both eyes with cloudy vision; however, the nurse's is able to see some. The customer reported that the nurse was instructed to keep her eyes close for the day.
 
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Brand NameBINAX NOW COVID-19 AG CARD
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
erina marshall
10 southgate road
scarborough, ME 04074
MDR Report Key11942318
MDR Text Key254372285
Report Number1221359-2021-01659
Device Sequence Number1
Product Code QKP
UDI-Device Identifier10811877011290
UDI-Public01108118770112901721041410129705
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-000
Device Lot Number129705
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
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 Treatment Data
Date Received: 06/04/2021 Patient Sequence Number: 1
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