MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ALPHA FETOPROTEIN (AFP); KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states observed falsely elevated alpha-fetoprotein (afp) results on atellica im 1600 analyzer for multiple patient(s) samples.The initial results were not reported to the physician(s).The samples were repeated on alternate atellica im analyzers, and the results were lower.The repeat results were considered as correct by the physician(s).The interpretation of results section of the atellica im alpha-fetoprotein (afp) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer observed falsely elevated alpha-fetoprotein (afp) results on atellica im 1600 analyzer for multiple patient(s) samples.The initial results were not reported to the physician(s).The samples were repeated on alternate atellica im analyzers, and the results were lower.The repeat results were considered as correct by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant elevated alpha-fetoprotein (afp) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00198 on sep 15, 2023.Additional information sep 29, 2023: a customer from outside the united states observed falsely elevated alpha-fetoprotein (afp) results on atellica im 1600 analyzer for multiple patient(s) samples.The initial results were not reported to the physician(s).The samples were repeated on alternate atellica im analyzers, and the results were lower.The repeat results were considered as correct by the physician(s).On (b)(6) 2023, the customer's moving average was failing so they performed a lookback of patient samples.They identified 16 discordant results showing a positive bias versus the repeat results.The lower repeat values were believed to be correct although the difference between values did not impact the clinical interpretation.Siemens investigation included an assessment of reagent pack id's, instrument health and sample/calibration and quality control (qc) data.No related errors were posted in the event log.Afp lot 263 calibration was acceptable and biorad immunoassay plus qc lot 85330 recovered within range.Review of internal data for atellica im afp reagent lot 263 shows that all acceptance criteria was met at release.The customer is operational and they continue to report qc and patients without further concern.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM ALPHA FETOPROTEIN (AFP)
• Type of Device: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17756322
• MDR Text Key: 324055159
• Report Number: 1219913-2023-00198
• 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: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995442
• Device Lot Number: 263
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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