MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR BR 27.29 (BR); BR 27.29 (BR) IMMUNOASSAY

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

A united states customer reported advia centaur xp cancer antigen 27.29 (br 27.29 (br) results of >450 u/ml were obtained from two samples from the same patient and questioned by the physician(s).The samples were auto diluted and gave over dilution errors.The two samples were repeated with the same instrument with manual dilutions, resulting lower.The customer has 2 samples from a patient with multiple myeloma and malignant neoplasma that recovered >450 u/ml with advia centaur br (ca 27.29) kit lot 260 when not diluted but upon 1/5 manual dilution recovered < 9 u/ml.Auto dilution of the samples gave over dilution errors.Siemens reviewed the calibration and control data provided and there is no evidence of a problem.The customer was not able to provide a list of medications/supplements the patient was taking.There is no sample that can be sent to siemens healthineers for evaluation.The patient sample had high levels of immunoglobulin g (igg) which is expected for a person with multiple myeloma.Some of the igg antibodies may be interfering with the advia centaur br (ca 27.29) assay.As stated in the limitation section of the advia centaur xp/xpt br instruction for use (ifu) (11206409)."heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays." dilutions are a way to help identify interference which explains why the diluted results did not match the undiluted results.The cause of the discrepant results seen by the customer with samples from this one patient when using advia centaur br kit lot 260 could not be determined but siemens cannot rule out pre-analytical factors or a sample issue.Based on the investigation, no product problem was identified.The customer is operational.No further action is needed.Mdr 1219913-2022-00074 was filed for different test dates.

Event Description

The customer reported advia centaur xp cancer antigen 27.29 (br 27.29 (br) results of >450 u/ml were obtained from two samples from the same patient and questioned by the physician(s).The samples were auto diluted and gave over dilution errors.The two samples were repeated with the same instrument with manual dilutions, resulting lower.It is unknown which results from the, advia centaur xp instrument were reported as the corrected result to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, advia centaur xp br 27.29 results.

• Brand Name: ADVIA CENTAUR BR 27.29 (BR)
• Type of Device: BR 27.29 (BR) 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 memishian ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13638992
• MDR Text Key: 289532302
• Report Number: 1219913-2022-00075
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414196664
• UDI-Public: 00630414196664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 10334837
• Device Lot Number: 260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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