• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS CENTAUR XP; REAGENT, CORONAVIRUS SEROLOGICAL Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIEMENS CENTAUR XP
Type of Device
REAGENT, CORONAVIRUS SEROLOGICAL
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
MDR Report Key10939958
MDR Text Key219499420
Report NumberMW5098172
Device Sequence Number1
Product Code QKO
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Number408049
Device Lot Number95041007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/02/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age92 YR
-
-