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

Catalog Number 691223

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/06/2022

Event Type  Injury  

Event Description

Suspected false positive results for bordetella pertussis with the qiastat-dx respiratory sars-cov-2 panel.

Manufacturer Narrative

No injuries were reported.Qiagen is reporting the incident in an abundance of caution and in accordance with the conditions of approval under the emergency use authorization for this product.The results for bordetella pertussis had a ct >30.The ifu instructs users to do a confirmatory specificity test for 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.

Manufacturer Narrative

No injuries were reported.Qiagen is reporting the incident in an abundance of caution and in accordance with the conditions of approval under the emergency use authorization for this product.The result for bordetella pertussis had a ct >30.The ifu instructs users to do a confirmatory specificity test for 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

Suspected false positive result for bordetella pertussis with the qiastat-dx respiratory sars-cov-2 panel.

• 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: davide manissero ; skelton house; lloyd street north; manchester, MA5 6-SH ; UK MA5 6SH
• MDR Report Key: 15950193
• MDR Text Key: 305161744
• Report Number: 3004013603-2022-00006
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Catalogue Number: 691223
• Device Lot Number: 220234
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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