MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOTAL HCG

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant total hcg result is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A false low advia centaur xp total hcg result was obtained for a patient sample.The patient sample was repeated on the same advia centaur xp and the result was higher.The patient sample was tested on the other advia centaur xp and the high result was confirmed.The high result was reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00006 on january 22, 2018.02/07/2018 additional information: the cause for the false low total hcg result is unknown.The falsely low result was not reproduced when the same sample was repeated on a later date with the same lot of total hcg reagent.In addition, the falsely low result was not confirmed when the same sample was tested on another advia centaur xp.Quality control and other patient samples were not affected.This issue only affected this patient sample.Since the precision is atypical for this sample, the issue may be preanalytical for this sample alone or instrument related.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG
• Common Device Name: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7210173
• Report Number: 1219913-2018-00006
• Device Sequence Number: 19023606
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K925277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 12866294
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1