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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report a discordant, falsely elevated advia centaur xp br (ca 27.29) result on a patient sample.A siemens customer service engineer (cse) was sent to the customer site and performed a total service call.The reagent probes (rp1, rp2, and rp3) positions were recalibrated.The reagent probe aspirations, acid and base pump dispensing, sample probe, and functional system checks were all acceptable.A quality control check by the customer and acceptable.The customer has updated their standard operating procedure (sop) to calibrate when replacing the ancillary readypack reagent.The advia centaur xp br instructions for use (10630988_en rev.T, 2020-02) states: "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results." based on in the information provided, no product non-conformance identified.The customer is operational.The instruction 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." the assay and instrument are performing within specifications.No further evaluation of the device is required.

Event Description

A falsely elevated advia centaur xp br (ca 27.29) result was obtained on a patient sample and it was considered discordant compared to a lower result when retested.The customer observed out of range quality control (qc) results the next morning.The ancillary reagent had been changed the previous afternoon.A br assay recalibration was performed using new reagent and ancillary reagents.Qc results were repeated and within acceptable ranges.The laboratory's medical director reviewed patient results, and a corrected report was issued for this patient.All other previously reported patient results were not questioned by the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, falsely elevated advia centaur xp br (ca 27.29) result.

• Brand Name: ADVIA CENTAUR XP BR (27.29)
• Type of Device: BR (27.29) 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 10809549
• MDR Text Key: 227024587
• Report Number: 1219913-2020-00498
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 10334837
• Device Lot Number: 248
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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