MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC ADVIA CENTAUR XP BR (27.29); SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Qc was in range at the time of the testing and there were no issues with any other samples.Siemens has requested the samples for testing.The instructions for use (ifu) under the interpretation of results states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2021-00256 was filed for a different sample from the same patient.

Event Description

The customer observed an elevated advia centaur xp br (ca 27.29) result for a patient sample compared to historical results and the clinical picture.A second sample was drawn from the patient and the result was also elevated.The second sample was tested on an alternate method and was lower and matched the clinical picture.The elevated results were not reported to the physician.There are no reports that treatment was altered or prescribed based on the elevated advia centaur xp br (ca 27.29) results.

Manufacturer Narrative

Mdr 1219913-2021-00257 was filed on may 14, 2021.May 26, 2021 - additional information the customer confirmed that the redrawn sample (sid 3116260) was tested on the alternate method on (b)(6) 2021.Siemens continues to investigate.Mdr 1219913-2021-00256 supplemental 1 was filed for a different sample from the same patient.

Manufacturer Narrative

Mdr 1219913-2021-00257 was filed on (b)(6) 2021 and mdr 1219913-2021-00257 supplemental 1 was filed on (b)(6) 2021.(b)(6) 2021 - additional information the customer has a patient sample (3112311) from a breast cancer patient that recovered 450 u/ml with advia centaur xp br (ca 27.29) kit lot 254 but when the sample was autodiluted 1/10 there was an error result.Manual 1/2, 1/5, and 1/20 dilutions produced diluted results < 30 u/ml.Previous br results for this patient were 23 u/ml in december 2020 and 73 u/ml in (b)(6) 2021.The patient was redrawn and the new sample (3116260) also recovered 450 u/ml.Siemens does not have any information indicating the medications the patient was taking would interfere with the advia centaur xp br assay.The samples were sent to siemens healthineers for evaluation.Siemens healthineers tested one of the samples with advia centaur xp br lots 254 and 256 and had results of 356 and 350 u/ml respectively so this is not a lot to lot issue.When the sample was treated with a non-specific antibody blocking tube (nabt), the treated sample recovered 88% lower with advia centaur br lots 254 and 256 indicating that non-specific antibodies (a type of heterophilic antibody) are elevating the result with the advia centaur br assay.As stated in the nabt instruction for use (ifu) "there may be some samples with extremely strong non-specific antibody interference.In such cases.The nabt may not be able to block all of the assay interference." siemens does not know what the true br concentration of the sample is.Dilutions are also a way to identify interference which explains why the diluted results did not match the undiluted results.As stated in the limitation section of the advia centaur xp/xpt br (ca 27.29) instruction for use (ifu) (11206409 revision u, 2020-03) "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.".The cause of the elevated results seen by the customer with samples from this one patient when using advia centaur xp br (ca 27.29) kit lot 254 were at least in part due to heterophilic (non-specific) antibody interference.Based on the investigation, no product problem was identified.Mdr 1219913-2021-00256 supplemental 2 was filed for a different sample from the same patient.

• Brand Name: ADVIA CENTAUR XP BR (27.29)
• Type of Device: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• MDR Report Key: 11826979
• MDR Text Key: 252436146
• Report Number: 1219913-2021-00257
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414196657
• UDI-Public: 00630414196657
• Combination Product (y/n): N
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: N/A
• Device Catalogue Number: 10333349
• Device Lot Number: 254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1