MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS CENTAUR XP; REAGENT, CORONAVIRUS SEROLOGICAL

Catalog Number 408049

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

Discrepant covid antibody test.Result = 1.00 (positive), rerun =.81 (negative) reported to siemens ref # 408049.Fda safety report id# (b)(4).

• Brand Name: SIEMENS CENTAUR XP
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.
• MDR Report Key: 10939958
• MDR Text Key: 219499420
• Report Number: MW5098172
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 408049
• Device Lot Number: 95041007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR