MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP; ALPHA-FETOPROTEIN (AFP) IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the cause of the discordant advia centaur xp afp result.The instructions for use states in the intended use section: "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 instructions for use states in the intended use warnings section: "elevated msafp (maternal serum afp) levels may indicate open ntd, but are not used to diagnose the defect without additional testing.In addition, elevated msafp levels may indicate other forms of fetal distress or malformation, which include placental malformations, ventral wall defects, fetal kidney dysfunction, and fetal death.Msafp levels may also be elevated in certain benign and malignant conditions not related to pregnancy.These conditions include hepatitis, cirrhosis, ataxia telangiectasia, primary hepatocellular carcinoma, and certain germ cell cancers.Furthermore, incorrect estimation of gestational age can result in either under- or over-estimation of open ntd risk.Therefore, afp testing requires accurate gestational dating for reliable risk assessment for open ntds.Confirmatory procedures such as ultrasonography, amniography, amniotic fluid acetylcholinesterase, and amniotic fluid afp must be used in conjunction with msafp testing for accurate ntd risk assessment." "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." "do not interpret serum afp as absolute evidence of the presence of malignant disease.At time of presentation, patients with confirmed non-seminomatous testicular cancer may have serum afp concentrations within the range observed in healthy individuals.Since elevated afp levels are often found in patients with other malignant and non-malignant conditions, the physician should rule out all other conditions associated with elevated afp levels prior to the use of the advia centaur afp values in non-seminomatous testicular cancer management.Conversely, low concentrations of afp are not necessarily indicative of absence of disease, particularly post-surgery or after chemotherapy.Testicular tumors that are histologically categorized as pure seminoma do not synthesize afp.The advia centaur afp assay, as a useful adjunct in cancer management, is intended for the evaluation of non-seminomatous testicular cancer, or mixed tumors with non-seminomatous elements, but not for pure seminoma.Additionally, several histologic subtypes of non-seminoma either do not synthesize afp (choriocarcinoma) or do so unpredictably (teratoma).Therefore, afp levels should be used concurrently with other diagnostic and clinical patient information.".

Event Description

A customer obtained an elevated advia centaur xp afp result for one patient, which was not expected based on the clinical picture of the patient.The result was not reported to the physician.The sample was retested using a different readypack.The retest results were lower, as expected.The retest results were reported to the physician.Quality control results were in range and no instrument errors were found with the system during the event.There is no indication that patient treatment was prescribed, delayed or altered.There was no report of adverse health consequences due to the discordant afp result.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00224 on august 28, 2020.Additional information from 09/24/2020: siemens has completed the investigation into an initial high result for advia centaur xp alpha fetal protein (afp) lot: 220.The customer received an initial result of 106.8 ng/ml but when repeated, obtained results of 1.8 ng/ml and 1.4 ng/ml, which matched the values expected by the customer.The customer did not report fliers with calibrations or controls and no further complaints have been received.The customer requested no further assistance.Siemens is unable to rule out preanalytical variables that may have attributed to the initial high results.Siemens' in house data was reviewed for advia centaur xp afp lot: 220 and no fliers were seen in patient panels, quality control or medical decision pools.Investigation is complete.Based on the investigation results, no product problem was identified.

• Brand Name: ADVIA CENTAUR XP AFP
• Type of Device: ALPHA-FETOPROTEIN (AFP) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10468948
• MDR Text Key: 204998685
• Report Number: 1219913-2020-00224
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (y/n): N
• PMA/PMN Number: D218416
• 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: 10/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 10309980
• Device Lot Number: 220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR