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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 08/13/2022

Event Type  malfunction  

Manufacturer Narrative

A customer from outside of the u.S.Reported observation of depressed atellica im alpha fetoprotein (afp) results which were discordant relative to repeat testing.The ifu states in the interpretation of results section: "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 reports observation of depressed atellica im alpha fetoprotein (afp) results which were discordant relative to repeat testing.Patient samples were re-tested on another atellica im instrument due to an observed negative shift in moving average for afp results.Higher 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

Mdr 1219913-2022-00306 was initially filed on 2022-09-15.Additional information, 2022-11-09: siemens has concluded the investigation.A customer from outside the united states reported observation of depressed atellica im alpha fetoprotein (afp) results which were discordant relative to repeat testing.Imprecision was observed for several samples when repeat testing was performed using different instruments.A low bias was seen for results produced by one instrument/reagent-pack combination, but quality control results were within range, and calibration did not demonstrate any bias.The affected samples were no longer available for additional testing.It is noted that the observed imprecision affected low-end afp results for a limited number of samples.Siemens cannot rule out sample-specific issues as a cause of the imprecision.A product performance issue has not been identified.The customer is operational, and has reported no additional discrepancies.No further investigation is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15432515
• MDR Text Key: 306174217
• Report Number: 1219913-2022-00306
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• 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