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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the non-reproduced discordant high advia centaur cp total human chorionic gonadotropin (hcg) result based on the information provided is unknown.However, pre-analytical variables such as the quality of the sample as the cause of the erroneous result cannot be ruled out.The customer continues to report quality controls, and patient results for hcg without further concerns.A system non-conformance has not been identified.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 evaluation of the device is required.
Event or Problem Description
A discordant high advia centaur cp total human chorionic gonadotropin (hcg) result obtained on a patient sample, and the result was questioned by the physician.The customer performed repeat hcg testing on the same sample, and the result was lower.A new sample was tested and the hcg result was lower.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
• Common Device Name: TOTAL HCG IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7948920
• Report Number: 1219913-2018-00250
• Device Sequence Number: 11326543
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 12/16/2018
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 029298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1