MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ALPHA FETOPROTEIN (AFP); ALPHA FETOPROTEIN ASSAY

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer observed a repeatedly high alpha fetoprotein (afp) result obtained on the atellica im.The one patient was repeatedly high around 90 ng/ml despite repeat testing or diluting out the sample.No serum left for this sample and this sample is not kept at the customer site.The patient is not known to have cancer and the only history is the patient was tested as part of a physical examination.It is unknown if the patient is pregnant, and no further history can be provided.The sample was negative on alternate platforms.Without additional testing or having further medical history, a potential root cause cannot be determined.Although diluting does dilute out interferences in some cases, it does not in all cases.Siemens does not have a root cause as to the elevated response.The instructions for use (ifu) under the interpretation of results section states the following: results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.As indicated in the ifu in the intended use section: the atellica® im alpha fetoprotein (afp) assay is for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein using the atellica® im analyzer for: human serum, plasma (edta and lithium heparin), and amniotic fluid from specimens obtained at 15-20 weeks gestation, as an aid in detecting open neural tube defects (ntds) when used in conjunction with ultrasonography and amniography testing.Human serum and plasma (edta and lithium heparin), as an aid in managing nonseminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.Additionally, in the ifu under the warning section: "the atellica im 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.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 atellica im afp values in non-seminomatous testicular cancer management.As the sample was tested outside the intended use of the assay, siemens can only provide plausible causes.Elevated afp results from a non-cancer patient could be associated with other liver conditions such as cirrhosis or hepatitis.Based on the investigation, no product non conformance was identified.The customer is operational.

Event Description

The customer observed discordant elevated results for a patient sample between atellica im 1600 alpha fetoprotein (afp) assay and alternate testing methods.The repeat result from alternate method 1 was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant afp results.

• Brand Name: ATELLICA IM ALPHA FETOPROTEIN (AFP)
• Type of Device: ALPHA FETOPROTEIN ASSAY
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15441896
• MDR Text Key: 300905864
• Report Number: 1219913-2022-00302
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995442
• Device Lot Number: 254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female