MAUDE Adverse Event Report: QIAGEN GMBH QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 691223

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

No injury was reported.Qiagen is reporting this incident in an abundance of caution and in accordance with the conditions of approval under the emergency use authorization for this product.The sample result had a ct >30.The ifu instructs users to do a confirmatory specificity test for a ct>29.The qiastat-dx respiratory sars-cov-2 panel healthcare provider fact sheet published alongside the ifu states laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

Event Description

A suspected false positive result for bordetella pertussis was obtained for 2 patient samples with the qiastat-dx respiratory sars-cov-2 panel, mat.691223.

• Brand Name: QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): QIAGEN GMBH; qiagen strasse 1; hilden, nrw 40724 ; GM 40724
• Manufacturer (Section G): QIAGEN GMBH; qiagen strasse 1; hilden, nrw 40724 ; GM 40724
• Manufacturer Contact: lindsey howard ; 19300 germantown rd.; germantown, md ; 6867826
• MDR Report Key: 10483257
• MDR Text Key: 205355944
• Report Number: 3004013603-2020-00013
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA200075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Catalogue Number: 691223
• Device Lot Number: 200107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2020
• 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
• Patient Outcome(s): Other