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

Model Number N/A

Device Problem High Readings (2459)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

A customer obtained an elevated atellica im alpha-fetoprotein (afp) result for one patient.The result was reported to the physician, who questioned the result.The same sample was re-tested the same day using the same reagent lot on another atellica im instrument, and a similarly-elevated result was produced.A gastric biopsy was performed the same day, indicating positive for gastritis, but negative for cancer.This diagnosis was considered definitive.A repeat test was requested, and a new sample was drawn and tested (atellica im, same reagents).The result for this sample was similar to those obtained in earlier testing.In order to investigate further, the customer also obtained test results from external laboratories (using atellica im and two alternate methods) for the same samples.The atellica im results reproduced the elevated observations seen in-house, while the alternate-method results were significantly lower.Mdr 1219913-2021-00369 was filed for the second observation of discordance on 21-jun-2021; mdr 1219913-2021-370 was filed for the third discordant observation, on 23-jun-2021.

Event Description

A customer obtained elevated atellica im alpha-fetoprotein (afp) results for one patient which were discordant relative to biopsy and alternate-test-method results.There was no report of adverse health consequences due to the discordant afp results.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-00368 initial report on 2021-06-30.Additional information - 2021-10-14.Siemens has concluded the investigation regarding elevated afp values obtained on the atellica im afp assay, lot 238.There was one patient that was continually elevated on the atellica im but much lower on alternate methodologies.The customer provided three samples which appear to be three draws from same patient.Siemens technical service laboratory (tsl) tested the returned customer samples using advia centaur lot 243 as well as atellica im lot 238.The results obtained were a mean dose of 110 ng/ml on the atellica im and a mean dose of 111 ng/ml on the advia centaur.Sample was also tested using a nabt (non specific antibody binding tube) and there was no reduction in dose.A root cause of the elevated response observed in customer testing and siemens testing could not be determined.According to the intended use section of the instructions for use (ifu): "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." since the customer tested outside the intended use of the assay, siemens can only provide plausible causes.Siemens can confirm that internal testing results comparable to the customer results were obtained on both the atellica im and advia centaur instruments, therefore, this issue does not appear to be an instrument specific.According to the warning section of the ifu, "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." there are a number of articles that elevated afp results from a non-cancer patient could be associated with other liver conditions such as cirrhosis or hepatitis.Siemens in house data was reviewed and a non conformance was not identified.Based on the information provided, a specific root cause could not be determined because the required information to further investigate this incident is not available.A product problem was not identified.No further evaluation of the device is required.In section h6, the type of investigation, investigation finding, and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2021-00369 supplemental 1 report was filed for the second observation of discordance on 21-jun-2021.Mdr 1219913-2021-00370 supplemental 1 report was filed for the third discordant observation, on 23-jun-2021.

• Brand Name: ATELLICA IM ALPHA-FETOPROTEIN (AFP)
• Type of Device: ALPHA-FETOPROTEIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12096173
• MDR Text Key: 259460496
• Report Number: 1219913-2021-00368
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• PMA/PMN Number: P930036
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995441
• Device Lot Number: 238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR