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 Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lots: m120943 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing batch records and quality control release testing for kit part number 190-000 / lots m120943 and test base part number 190-430 / lots m120943 were reviewed.This lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot m120943 showed the complaint rate = (b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(4), inc.Was unable to determine the exact root cause of the reported issue.The available evidence suggests that this device lot is performing within the statements made within package insert related to % test agreement with the expected results by sample concentration.

Event Description

A customer reported a false negative result on a direct nasopharyngeal swab (copan flocked swab) with the id now covid-19 test.The customer stated the sample was tested immediately after collection.Confirmation testing with bd max on an np sample (not otherwise specified) eluted in 1 ml bd utm generated positive covid-19 results.Confirmation sample collection and testing dates were not provided.Additional patient information, including symptoms, treatment, impact and outcome, were not provided.Attempts to collect additional information were not successful.Note: on 6 july 2020 fda provided the following letter to health care providers: https://www.Fda.Gov/medical-devices/letters-health-care-providers/false-positive-results-bd-sars-cov-2-reagents-bd-max-system-letter-clinical-laboratory-staff-and 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.Additionally, 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: 10318116
• MDR Text Key: 255448899
• Report Number: 1221359-2020-00164
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 011081187701126910M120943
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: 190-000
• Device Lot Number: M120943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• 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