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

Catalog Number 10995442

Device Problem High Test Results (2457)

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

Event Date 08/13/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the us customer (ous) reported an observation of elevated atellica im alpha fetoprotein (afp) patient results which were discordant relative to repeat testing.The intended use according to the instructions for use (ifu) is as follows: "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 non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures." the ifu indicates the following: "warning use afp results only as part of the overall clinical evaluation of a patient.Do not use afp results as the only criterion for diagnosis." "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." the interpretation of results section in the ifu states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Event Description

The customer reported an observation of elevated atellica im alpha fetoprotein (afp) patient results which were discordant relative to repeat testing.The patient samples were re-tested on another atellica im instrument due to an observed shift in moving average for afp results.Lower results were obtained upon repeat testing, and accepted as correct.There are no allegations of patient intervention or adverse health consequences due to the discordant afp results.

Manufacturer Narrative

Siemens filed mdr 1219913-2022-00309 initial report on 2022-09-20.Additional information 2022-09-21: device was not serviced by a third party; section d8 of this report was updated accordingly.Additional information - 2022-10-18: siemens has concluded the investigation for an outside of the united states (ous) customer for an observation of elevated atellica im alpha fetoprotein (afp) results which were discordant relative to repeat testing.The patient samples were run on reagent pack id (b)(6) (lot 254).Initial results were reported to physician(s) and were questioned and retested, but corrected reports were not issued.The customer noted a positive bias in the moving average and initial patient results.In review of the moving average, it does appear there were two points with >2 standard deviation (sd) for the moving average.It does appear the moving average did come back down on subsequent packs.The quality control (qc) on pack (b)(6) was not significantly different than other packs, however, all patients that were elevated were run on this pack.Patients were not repeated on this specific pack.The customer has not observed any further issues with repeat sample results not matching initial results.Data provided does suggest that the issue may be related to this specific pack, however, the pack was no longer available for testing.Siemens reviewed in-house reagent release data for lot 254 and no imprecision was noted with any of the release testing.Based on the investigation, no product problem was identified.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM ALPHA FETOPROTEIN (AFP)
• Type of Device: AFP IMMUNOASSAY
• 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: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 15454024
• MDR Text Key: 306327654
• Report Number: 1219913-2022-00309
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/04/2023
• Device Catalogue Number: 10995442
• Device Lot Number: 254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• 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