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

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.

• 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 Key: 10324522
• MDR Text Key: 229099346
• Report Number: 1221359-2020-00166
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA2000074
• Number of Events Reported: 1
• 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 Number: 190-000
• 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 Received: 07/26/2020
• 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 Number: 1