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 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens investigation is complete.The customer resulted a (b)(6) thcg result that was questioned by the physician.The sample repeated (b)(6) several times but was a much higher dose value than the originally reported 57 miu/ml.Hsc has reviewed the information provided to determine probably cause for the initial low result.Samples run around the time of this initial low result all repeated as expected and qc was in range so service was not sent.This is a sample specific issue.The same sample/same tube was repeated several times on the same reagent lot on this system and other centaurs in the lab and all results matched well and were at the higher dose value ~950 miu/ml.Preanalytic variables can affect the quality of the sample and can lead to erroneous results.While there is insufficient information to determine the cause of the false results, we cannot rule out preanalytic factors leading as the causative agent for the initially low result.No product performance issue is confirmed.The ifu states in the interpreataion of results section: "interpretation of 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: "all in vitro assays can generate erroneous results, both clinically false (b)(6) results (test results suggesting a condition that is absent) and clinically false (b)(6) results (test results failing to identify a condition that is present).If an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory.Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant 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." no further evaluation of the device is required.

Event Description

A (b)(6) result was obtained using the advia centaur xp total hcg assay, which was reported to the physician as (b)(6).The physician requested quantitative results for the patient and the sample was run in triplicate.Results obtained were (b)(6), but a higher concentration was obtained that the initial result, therefore the sample was flagged with a delta error.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 5086608576
• MDR Report Key: 8750743
• MDR Text Key: 214141903
• Report Number: 1219913-2019-00120
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2019

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: 11/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 49942305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1