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 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of an elevated atellica im alpha fetoprotein (afp) result which was discordant relative to clinical history and repeat testing.Quality control (qc) results were acceptable, and no other problem indications were reported.The assay's instructions for use (ifu) states the following, under interpretation of results: ¿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 an elevated atellica im alpha fetoprotein (afp) result for a male patient which was discordant relative to clinical history and repeat testing.Afp kit lot 263 was in use at the time.An elevated afp result was obtained for an 83-year-old male patient.The result was considered inconsistent with previous test history, so the sample was repeat-tested multiple times on the same instrument, producing consistently lower results.The lower results were accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

Manufacturer Narrative

Mdr 2432235-2023-00185 was initially reported on 2023-06-23.A customer from outside the united states reported observation of an elevated atellica im alpha fetoprotein (afp) result for an 83-year-old male patient which was discordant relative to clinical history and repeat testing.The sample was repeat-tested multiple times on the same instrument, producing consistently lower results, which were accepted as correct.Quality control (qc) results were acceptable, and no other sample issues or problem indications were reported.Siemens reviewed the log data from the customer instrument.No issues were noted with aspiration or dispense of reagents for the discordant test.Although the sample aspiration was within acceptable limits, the record for the affected sample shows a slight variation in pressure as compared to other 10-¿l sample aspirations.The likely cause for the observed pressure variation is presence of micro-fibrin in the sample.No issues were observed with the sample dispense.Based on the available information, the cause of the discordant result consistent with a sample integrity issue.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.The customer is operational, and no further action 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: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 511 benedict ave.; tarrytown, NY 10591 ; 5082985306
• MDR Report Key: 17192181
• MDR Text Key: 318005632
• Report Number: 2432235-2023-00185
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• 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: 10995441
• Device Lot Number: 263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male