MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 1600 ALPHA FETOPROTEIN (AFP); KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

Customer observed an elevated alpha fetoprotein (afp) result from one patient on the atellica im 1600 that did not match the clinical picture of the patient.Repeat testing of the same sample on the atellica im 1600 produced elevated results.The sample was manually diluted, and again produced elevated results.Repeat testing on two alternate methods was performed, producing negative results.The atellica im afp results were not reported to the physician(s).The result from the first alternate method was reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated atellica im afp results.

Manufacturer Narrative

An outside the united states customer reported an elevated atellica im afp results for a 54 year old male with no indication of a cancer diagnosis.The results were elevated compared to the clinical picture and two alternate method results.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." siemens healthcare diagnostics is investigating.

Manufacturer Narrative

The initial mdr 1219913-2022-00163 was filed on may 31, 2022.Additional information - july 5, 2022.An outside the united states customer reported an elevated atellica im afp results for a 54 year old male with no indication of a cancer diagnosis.The results were elevated compared to the clinical picture and two alternate method results.The sample resulted as 176.3 ng/ml and repeated as 184.3 ng/ml and 176.2 ng/ml.The alternate methods indicated a low value which was expected.The customer tried diluting out the sample to try and dilute out potential interference however the values did not become lower.As per the instructions for use 10995310_en rev.03, 2020-02, 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." in house data was reviewed for afp kit lot 250 and all release criteria was met.The customer has not reported further discrepants.The "issue" appears related to this one sample potentially demonstrating a non specific interference.Should the customer get a list of medications or patient history, siemens can work to try and determine a possible root cause.No further action required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM 1600 ALPHA FETOPROTEIN (AFP)
• Type of Device: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• 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: 14552986
• MDR Text Key: 300593549
• Report Number: 1219913-2022-00163
• 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,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995441
• Device Lot Number: 250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2021
• 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: 54 YR
• Patient Sex: Male