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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW 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 Eye Burn (2523); Eye Pain (4467)
Event Date 07/06/2022
Event Type  Injury  
Event Description
The customer reported that a nurse at their facility had accidently used the solution of the binaxnow covid-19 ag card as eye drops on herself by mistake. They reported eye irritation and burning sensation.
 
Manufacturer Narrative
Technical service provided the safety data sheet to the customer and no further action is required. According to the package insert in19500 v 3. 0 21. The extraction reagent packaged in this kit contains saline, detergents and preservatives that will inactivate cells and virus particles. Samples eluted in this solution are not suitable for culture. Based on the above summary, the investigation is deemed complete. The product will continue to be monitored and tracked.
 
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Brand NameBINAXNOW 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
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key15007769
MDR Text Key295857317
Report Number1221359-2022-03584
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeAF
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number195-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
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 Treatment Data
Date Received: 07/13/2022 Patient Sequence Number: 1
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