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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN Back to Search Results
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.
 
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Brand NameADVIA CENTAUR XP AFP ASSAY
Type of DeviceKIT, 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 Key8199928
MDR Text Key132503650
Report Number1219913-2018-00308
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K020806
Number of Events Reported1
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 Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/15/2018
Device Model NumberN/A
Device Catalogue Number10309980
Device Lot Number041199
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 Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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