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

Catalog Number 190-000

Device Problem Use of Device Problem (1670)

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

Event Type  Injury  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported an increase of invalid results with the id now covid-19 assay for multiple patients over various dates.This mfr.Report is one of four and addresses invalids which occurred in (b)(6).The customer reported thirty-five invalid results with the id now covid-19 assay on direct tested nasopharyngeal and nasal swabs (miraclean technology) for the month of (b)(6).Repeat testing also generated invalid results which resulted in a 1.5 hour delay as the sample had to be recollected for testing using the cepheid platform (results not provided).Per the customer, no patient harm occurred; however, the patients could not be admitted until the test results were back.Additionally, per the customer the delay impacted the entire hospital due to delays in freeing bed space.

Manufacturer Narrative

This supplemental report is being submitted to correct the lot number and to provide the investigation conclusion.Please see updates: d4, g3, g6, h2, h4 and h6.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot m159709 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number190-000 / lot m159709.Test base part number 190-430 / lot m159709.The lot met the required release specifications.(b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is sample interference.Abbott scarborough diagnostics was able to determine from the logfile that the majority of the invalid results were due to unknown sample interference.Substances in the sample itself may have interfered with the reaction.It was also observed that some of the invalids were also due to sample transfer errors.Based on the above summary, the investigation is deemed closed.The product will continue to be monitored and tracked.

• Brand Name: ID NOW COVID-19 ASSAY
• Type of Device: MOLECULAR IVD FOR ID NOW COVID-19,
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough,; ME 04074
• Manufacturer Contact: erina marshall ; 10 southgate road; scarborough,
• MDR Report Key: 12380670
• MDR Text Key: 268913523
• Report Number: 1221359-2021-02426
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 01108118770112691721111110M159709
• 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
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2021
• Device Catalogue Number: 190-000
• Device Lot Number: M159709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2021
• 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
• Patient Outcome(s): Other