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

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	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the false positive advia centaur xpt total hcg result is unknown, and may be attributed to specimen collection and handling.The original patient sample was not able to be repeated.There was no report of quality control issues, and no errors observed from the system error log at the time of the event.There was no report of imprecision with the advia centaur xpt total hcg assay.The customer repeats all sample results up to 200 miu/ml, and did not observe any other discordant test results.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)." "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 or Problem Description
A false positive advia centaur xpt total human chorionic gonadotropin (hcg) result obtained by the customer, and the reported result was questioned by the physician.A new patient sample was drawn, and the result was negative.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 xpt total hcg result.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG ASSAY
• Common Device Name: TOTAL HCG IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 6835629
• Report Number: 1219913-2017-00188
• Device Sequence Number: 13810593
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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 Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR