MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT AFP ASSAY; AFP 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	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant afp results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the warning section: "warning: the concentration of afp in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the afp assay used.Values obtained with different afp assay methods cannot be used interchangeably.Before changing assay methods, the laboratory must do the following: for prenatal testing, the laboratory must establish a range of normal values for the new assay based on normal serum and amniotic fluid from pregnant women with a confirmed gestational age.For cancer management, the laboratory must perform additional testing to confirm baseline values for patients being serially monitored.United states federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.Use afp results only as part of the overall clinical evaluation of a patient.Do not use afp results as the only criterion for diagnosis." the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A false high advia centaur xpt afp result was obtained for a patient sample.The patient was tested a month later for afp and the result was low.The patient sample was tested on an alternate method for confirmation and the result was low.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant afp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00019 on 02/08/2019.03/08/2019 additional information: for section e4 of the initial mdr report, the answer received is "no".The quality control (qc) and calibrations were within range at the time of the event.Service was not sent for the instrument because no other test issue was reported.The qc for all the other tests were acceptable for the customer.Based on limited information currently available in the complaint, siemens cannot evaluate any service intervention for probable cause of the questionable patient sample result.Siemens has made multiple attempts to gather information for an issue that occurred approximately six months prior without regional response.It could not be ruled out that a preanalytical sample variable contributed to the questionable initially high patient sample result.Since the issue was related to a singular patient sample result there is no indication that an instrument mechanical failure contributed to the questionable result.The instrument is performing within specifications.No further evaluation of the device is required.
Additional Manufacturer Narrative
The initial mdr 1219913-2019-00019 was filed on 08-feb-2019.The first supplemental report was filed on 02-apr-2019.Correction (18-feb-2022): the (initial) mdr had the incorrect date of 28-dec-2018 for the "date received by manufacturer" field.The correct date is 04-dec-2018.

• Brand Name: ADVIA CENTAUR XPT AFP ASSAY
• Common Device Name: AFP 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; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 8323770
• Report Number: 1219913-2019-00019
• Device Sequence Number: 14042889
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2022

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: 01/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309980
• Device Lot Number: 041196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 03/08/2019; 02/18/2022
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/02/2019; 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male