MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, 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	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the non-reproducible advia centaur cp total human chorionic gonadotropin (thcg) results is being investigated by siemens.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 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.".
Event or Problem Description
Customer observed non reproducible advia centaur cp total hcg (thcg) results on one instrument.There are no reports that treatment was altered or prescribed or adverse health consequences due to the non reproducible advia centaur cp thcg results.
Additional Manufacturer Narrative
Mdr 1219913-2019-00015 was filed on february 11, 2019 reporting non-reproducible results with the thcg assay on the advia centaur cp on one sample.March 13, 2019 - additional information root cause was not identified.The customer reported no calibration or control performance issues although data was not provided.The integrity of the sample cannot be ruled out as the cause of the variability seen.Imprecision can be caused by pre-analytical issues including incomplete clotting or sample integrity in general.Customer has not reported further occurrences.No further investigation is required.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG ASSAY
• Common Device Name: TOTAL HCG IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8325269
• Report Number: 1219913-2019-00015
• Device Sequence Number: 2253730
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 43537301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1