MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient results is unknown. The customer's assay calibration and quality controls (qc) were acceptable. The customer informed siemens that initial afp concentrations were not above the assay measurement range. For example: the sample from (b)(6) had an initial afp result of 7. 5 ug/l, when pre-diluted with negative serum pool and tested the next day, the results were 1. 7 ug/l (1:10), 14. 5 ug/l (1:20), 49. 8 (1:200) and eventually yielding a result of > 1000 ug/l. Siemens is investigating the event. 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. " mdr 1219913-2018-00309 was filed for an elevated afp result on the same patient on a different day.

Event Description

Falsely elevated advia centaur xp alpha-fetoprotein (afp) results were observed on a patient sample and questioned by the physician. The patient was transferred to another hospital for a liver transplantation in (b)(6) 2018, however the afp measured at this hospital was normal. The patient was discharged with no abnormality detected. There are no reports of adverse health consequences due to the discordant advia centaur xp afp results. Mdr 1219913-2018-00309 was filed for an elevated afp result on the same patient on a different day.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Type of Device: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN
• 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: 8199928
• MDR Text Key: 132503650
• Report Number: 1219913-2018-00308
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K020806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309980
• Device Lot Number: 041199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial