MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SARS COV2T ANTIBODY TEST SIEMENS CENTAUR XP; REAGENT, CORONAVIRUS SEROLOGICAL

Model Number CENTAUR XP

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

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

Event Date 10/05/2020

Event Type  malfunction  

Event Description

Discrepant covid antibody test result, result = 1.11 (positive), rerun = 0.61 (negative).Result = 1.11 (positive), rerun = 0.61 (negative), siemens notified (8th result reported) siemens lot #006.Fda safety report id# (b)(4).

• Brand Name: SARS COV2T ANTIBODY TEST SIEMENS CENTAUR XP
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.
• MDR Report Key: 10656562
• MDR Text Key: 211021008
• Report Number: MW5097151
• Device Sequence Number: 1
• Product Code: QKO
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CENTAUR XP
• Device Catalogue Number: 10310681
• Device Lot Number: 006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 70 YR