MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR SARS-COV-2 IGG (SCOVG) ASSAY

Model Number N/A

Device Problem Failure to Calibrate (2440)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

The customer reports observation of calibration failure due to low calibrator deviation when using advia centaur xp sars-cov-2 igg (scovg) assay.There are no known reports of patient intervention or adverse health consequences due to the scovg calibration failure.

Manufacturer Narrative

A customer from the united states observed calibration failure due to low calibrator deviation when using the advia centaur xpt sars-cov-2 igg (scovg) assay.There are no allegations of patient harm, changes in treatment, or diagnostic delays due to the observed calibration failure.Siemens healthcare diagnostics is investigating the observed problem.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00402 on november 18, 2022.December 13, 2022 additional information: siemens healthcare diagnostics inc.Investigation confirmed that the failed calibrations are due to the standard s01 value in the master curve card (mcc) for the advia centaur systems lots 19529015 and 27236015, being set at 0.1 index.The s01 value should be 0.01 index.The issue is isolated to the advia centaur systems scovg lots 19529015 and 27236015, smns 1120376 and 1120379.Customers were notified of the issue and instructed to discontinue use of the kits.(us: cc 23-01.A.Us was sent to us customers on 2022-12-16 and outside the us: cc 23-01.A.Ous was sent to customers on 2022-12-16 who have received the advia centaur systems sars-cov-2 igg (scovg) lots 19529015 and 27236015).In section h6, the type of investigation, investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR SARS-COV-2 IGG (SCOVG) ASSAY
• Type of Device: SARS-COV-2 IGG (SCOVG) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15824257
• MDR Text Key: 303934093
• Report Number: 1219913-2022-00402
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202670
• 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

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 11207376
• Device Lot Number: 015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1