MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP TOTAL HCG ASSAY; TOTAL HCG IMMUNOASSAY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer's site for system inspection.The cse checked the air pump calibrations, sample probe diluter fluidics, and adjustments were made to the air pump flow range.The cse checked quality control, and a patient run that were acceptable.The cause of the non-reproduced false low advia centaur cp total human chorionic gonadotropin (hcg) result may be due to sampling issues.No additional concerns have been reported by the customer.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) under the limitation section states the following: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present)." "there are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents." "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 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." the instrument is performing within specification.No further investigation is required.

Event Description

A false low advia centaur cp total human chorionic gonadotropin (hcg) result obtained by the customer on a patient sample, and the reported result was questioned by the physician (patient).The same sample was repeated the following day, and the result was higher.The patient was redrawn, tested on a different analyzer, and the result was high.A corrected report was issued.There was no report of patient treatment being prescribed or altered, or adverse health consequences due to the discordant advia centaur cp total hcg result.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG ASSAY
• Type of Device: TOTAL HCG IMMUNOASSAY
• 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 7184463
• MDR Text Key: 97740231
• Report Number: 1219913-2017-00261
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 029294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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