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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

The siemens fas provided the following information: the sample was tested from primary tubes.It was inspected for fibrin and recentrifuged.Other samples were repeated without changes or concerns for the result.The customer had not any further concerns with total hcg.This was an isolated event.The cause for the discordant total hcg results 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." the ifu states in the limitations section: "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts.".

Event Description

A false high advia centaur xp total hcg result was obtained on a patient sample.Another sample was tested at a later date and the result was negative.Both samples were repeated on another advia centaur xp and the results negative.The siemens field application specialist (fas) went on site and tested both samples.The results were negative.The negative results were considered correct as they matched the report from the physician of the patient's menstruation.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00157 on august 19, 2019.On 08/23/2019 additional information: the customer reports a single discordant advia centaur xp total hcg patient sample on (b)(6) 2019.The higher than expected result was questioned and the sample was repeated multiple times on more than one advia centaur and all replicates were negative.Quality control and other patient samples were not affected.This issue only affected this patient sample.The sample was checked for fibrin and re-centrifuged before being repeated.All other samples from this day repeated with no concerns for the results.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the single high discordant result, siemens cannot rule out pre-analytical factors or sample specific issue.A systemic product issue has not been confirmed.The customer continues to report thcg controls and patients without further concern.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG (THCG)
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8908508
• MDR Text Key: 208023204
• Report Number: 1219913-2019-00157
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 64460307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1