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

Catalog Number 191-000

Device Problems False Positive Result (1227); Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

The customer reported nine (9) false/unexpected results with the id now covid-19 instrument for multiple patient samples performed on unknown dates as part of validation studies.This mfr.Report addresses false result three (3) of nine (9).The customer reported a false/unexpected result with the id now covid-19 instrument performed on unknown dates on a patient sample.Although requested, no additional information was provided.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Reference mfr no 221359-2022-04824,1221359-2022-04837 through 1221359-2022-04844.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion and corrections to b5, h6 "medical device problem code".The required intake information to enable further investigation, such as the kit's lot number and logfiles, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.Please see related mfr report numbers: 1221359-2022-04837 through 1221359-2022-04844.

Event Description

The customer reported nine (9) false/unexpected results with the id now covid-19 instrument for multiple patient samples performed on unknown dates.This mfr.Report addresses test result three (3) of nine (9).The customer reported a false positive result with the id now covid-19 instrument performed on unknown dates on an unknown sample type.Pcr confirmation testing was performed with aus diagnostics platform and generated a negative result.Although requested, no additional information was provided.

Manufacturer Narrative

This report is being submitted to provide additional information to the investigation completion.Per (b)(6), the customer performed the id now covid-19 positive neqas swab as a qc test and received a failing result.Per the investigation, this is the expected / intended result for the positive control swab as it is coated with covid-19 virus instead of inactivated influenza a and b viruses in the abbott control.There has been no malfunction of the assay.

• Brand Name: ID NOW COVID 19 ASSAY
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• 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 Key: 15492387
• MDR Text Key: 301033720
• Report Number: 1221359-2022-04838
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 191-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• 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 Sequence Number: 1