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

Lot Number 95041007

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

Patient Problem Test Result (2695)

Event Date 12/10/2020

Event Type  malfunction  

Event Description

Discrepant covid antibody test result.Result = >10 (positive), rerun =.63 (negative) reported to siemens ref# (b)(4).Fda safety report id# (b)(4).

• Brand Name: SIEMENS CENTAUR XP SARS COV2T ANTIBODY TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.
• MDR Report Key: 11018821
• MDR Text Key: 222025636
• Report Number: MW5098378
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 95041007
• 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: 79 YR