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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT ID NOW COVID 19; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Virus (2136)
Event Date 05/29/2020
Event Type  malfunction  
Event Description
Abbott id now covid rapid test failed to detect covid 19 infection.Resulted in high risk exposure event to medical staff.
 
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Brand Name
ABBOTT ID NOW COVID 19
Type of Device
REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key10114088
MDR Text Key193947882
Report NumberMW5094797
Device Sequence Number1
Product Code QJR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/31/2020
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 No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/02/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age89 YR
Patient Weight77
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