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 False Positive Result (1227)

Patient Problems Fatigue (1849); Headache (1880); Neck Pain (2433); Eye Pain (4467)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Reference mfr.Report: 1221359-2021-02039, 1221359-2021-02040, 1221359-2021-02042, 1221359-2021-02043, 1221359-2021-02044, 1221359-2021-02045, 1221359-2021-02046.The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported eight (8) false positive results with the id now covid-19 assay for muliple patients.This mfr.Report addresses patient three (3) of eight (8).The customer reported a false positive results with the id now covid-19 assay performed on (b)(6) 2021 on a direct tested nasal kitted swab.Repeat testing was not performed.Pcr confirmation testing performed on (b)(6) 2021 (sample type not provided ) generated a negative result.The customer stated the patient was symptomatic with a headache/ eye pressure/ neck pain and fatigue, three ( 3) days.The customer reported the patient quarantine.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Manufacturer Narrative

Investigation: 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 number 190-000 / lot m159709 and test base part number 190-430 / lot m159709.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot m159709 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.

• 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: naissa bogard ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12200626
• MDR Text Key: 281157325
• Report Number: 1221359-2021-02041
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Catalogue Number: 190-000
• Device Lot Number: M154844
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2021
• 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 Age: 11 YR
• Patient Sex: Male
• Patient Weight: 39 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White