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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19; MOLECULAR IVD FOR ID NOW COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19; MOLECULAR IVD FOR ID NOW COVID-19 Back to Search Results
Catalog Number 190-000
Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The required information to enable further investigation, such as the kit's lot number, was not available and therefore a root cause investigation was not performed.A review of complaints' trend reveal that all of the id now covid-19 test kits within expiry are performing according to label claims.The exact root cause of the reported issue could not be determined.
 
Event Description
A customer reported two false negative results on direct nasopharyngeal swabs (not otherwise specified) with the id now covid-19 test.The customer did not provide any information on confirmation testing.Additional patient information, including symptoms, treatment, impact and outcome, were not provided.Attempts to collect additional information were not successful.The id now covid-19 product insert indicates that negative results should be treated as presumptive and tested with an alternative fda authorized molecular assay, if necessary for clinical management, including infection control.The pi states negative results do not preclude sars-cov-2 infection and should not be used as the sole basis for patient management decisions.Negative results must be combined with clinical observations, patient history, and epidemiological information.Additionally, the id now covid-19 product insert includes a limitation that false negative results may occur if a specimen is improperly collected, transported or handled.False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate levels of viruses are present in the specimen.Due to the risk of a potential false negative result leading to no or delayed treatment, this event shall be considered reportable.
 
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Brand Name
ID NOW COVID-19
Type of Device
MOLECULAR IVD FOR ID NOW COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough, me
Manufacturer Contact
erin rowley
10 southgate road
scarborough, me 
7305858
MDR Report Key10324522
MDR Text Key229099346
Report Number1221359-2020-00166
Device Sequence Number1
Product Code QJR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA2000074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/25/2020
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 Health Professional
Device Catalogue Number190-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/26/2020
Initial Date FDA Received07/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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