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

Catalog Number 190-000

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

The customer reported six false positive results with the id now covid-19 assay on a id now instrument.Technical services (ts) inquired further on the details surrounding this allegation such as date of occurrence or patient identifiers, in which the customer did not provide any further information on this allegation.No adverse patient effects were reported.No additional patient information, including treatment and outcome, was provided.This manufacturer report addresses false positive result 1 of 6.

Manufacturer Narrative

The required intake information to enable further investigation, such as the kit's lot number, 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 (b)(4) was unable to determine the exact root cause of the reported issues as no information was provided for investigation.Related reports: case(b)(6)_1221359-2021-03861-in, case (b)(6)_1221359-2021-03968-in, case (b)(6)_1221359-2021-03969-in, case (b)(6)_1221359-2021-03970-in, case (b)(6)_1221359-2021-03972-in.

• 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 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13119580
• MDR Text Key: 283322094
• Report Number: 1221359-2021-03971
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EUA2000074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190-000
• Date Manufacturer Received: 12/01/2021
• 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