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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP AFP IMMUNOASSAY

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP AFP IMMUNOASSAY Back to Search Results
Model Number N/A
Device Problems Off-Label Use (1494); High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens healthcare diagnostics is investigating. The patient is a (b)(6) male with no indication of a cancer diagnosis; customer tested outside of the intended use of the assay. The intended use section of the instructions for use (ifu) states: "for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (afp) in the following: human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neural tube defects (ntds) when used in conjunction with ultrasonography and amniography testing human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the advia centaur® xp and advia centaur xpt® systems. " the warnings section of the ifu states: "the advia centaur afp assay is not a screening test for cancer and must never be used as such. Afp testing is a safe and effective supplement to patient care when used as part of the overall management strategy for patients undergoing treatment for non-seminomatous testicular cancer or for patients being monitored after therapy is complete. " the interpretation of results section of the ifu states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " mdr 1219913-2021-00409 was filed for results from (b)(6) 2021 on advia centaur xp #2. Mdr 1219913-2021-00410 was filed for results from (b)(6) 2021, instrument # not provided.
 
Event Description
A customer observed discordant elevated advia centaur xp afp results for one sample from a (b)(6) male patient. The initial result was higher than was expected (according to the customer, the expected value <8. 1 ng/ml). The customer performed manual dilution testing at dilutions of 1:2, 1:4 and 1:8 on the same day, on the same instrument; the results were also higher than expected. The customer retested the same sample on a different advia centaur xp instrument and the result was also higher than expected. The advia centaur xp results were not reported to physician(s). The same sample was retested on an alternate afp method and the result was lower and agrees with the clinical picture of the patient. The customer provided an historical advia centaur xp afp result for this patient (tested (b)(6) 2021) that was also elevated. This result was reported to the physician, but it is unknown if the result was questioned. There are no known reports of patient intervention or adverse health consequences due to the discordant afp results.
 
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Brand NameADVIA CENTAUR XP AFP
Type of DeviceAFP IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591 5097
MDR Report Key12284520
MDR Text Key280815864
Report Number1219913-2021-00408
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
PMA/PMN Number
D030659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number10309980
Device Lot Number232
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No

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