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

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 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.The patient is a 35 year old 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 1219913-2021-00408 was filed for results from (b)(6) 2021 on advia centaur xp #1.Mdr 1219913-2021-00409 was filed for results from (b)(6) 2021 on advia centaur xp #2.

Event Description

A customer observed discordant elevated advia centaur xp afp results for one sample from a (b)(6)-year-old 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 2021-06-08) 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.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-00410 initial report on august 5, 2021.Additional information - 2021-08-12: siemens has completed the investigation into elevated afp results from one patient obtained on different advia centaur instruments compared to the result of an alternate method.The initial result was 403.5 ng/ml on advia centaur systems afp kit lot 232.The sample was diluted out serially, but the sample did not dilute (results remained elevated).The customer expected value was 8.1 ng/ml, which was obtained on the alternate method.The patient was not a cancer or maternal patient.The intended use of the assay is for known cancer patients or maternal screening patients.Sample is not available to be sent in for further evaluation.No root cause could be identified.No further discrepant results were reported by this customer.Siemens' internal lot release data was reviewed for afp kit lot 232 and no issues were observed.No product problem was identified.Customer is operational.No further action is needed.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2021-00408 supplemental 1 report was filed for results from (b)(6) 2021 on advia centaur xp #1.Mdr 1219913-2021-00409 supplemental 1 report was filed for results from (b)(6) 2021 on advia centaur xp #2.

• Brand Name: ADVIA CENTAUR XP AFP
• Type of Device: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12284511
• MDR Text Key: 265435697
• Report Number: 1219913-2021-00410
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (y/n): N
• PMA/PMN Number: D030659
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 10309980
• Device Lot Number: 232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR