MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP TOTAL HCG (THCG) ASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

The customer from (b)(6) obtained a discordant elevated advia centaur cp - total hcg (thcg) result for one female patient sample.The initial result was reported to the physician, who questioned the result.The sample was repeated on the same advia centaur system, and the result was lower.The interpretation of results section of the advia centaur cp total hcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.

Event Description

The customer obtained a discordant elevated advia centaur cp - total hcg (thcg) result for one female patient sample.The initial result was reported to the physician, who questioned the results.The sample was repeated on the same advia centaur system, and the result was lower.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur cp total hcg result.

Manufacturer Narrative

Initial mdr 1219913-2023-00049 was filed on march 15, 2023 reporting a customer from united states obtained a discordant elevated advia centaur cp - total hcg (thcg) result for one female patient sample.The initial result was reported to the physician, who questioned the result.The sample was repeated on the same advia centaur cp system, and the result was lower.Additional information on march 22, 2023: service replaced the reagent syringe on (b)(6) 2023.The customer had no further concerns with the instrument or thcg performance since service.No further support is required.Additional information on march 24, 2023: the customer reported a falsely elevated discordant patient result on advia centaur cp total hcg (thcg) reagent lot 345.On (b)(6) 2023, a patient resulted as 570 miu/ml which was questioned by the physician.The same sample was repeated and resulted as <5 miu/ml.The lower repeat value was issued with a corrected report.The calibration of thcg reagent lot 345 was valid and biorad quality control (qc) lots 40400 and 42293 recovered within range on the day of this event.The customer pulled thcg samples that ran before and after the discordant sample and all three of those samples repeated similar to the initial result.Service was dispatched and learned that on (b)(6) 2023 the operators cleaned up a substantial amount of a liquid substance from the top of the incubation ring cover.There was evidence of a spill, and it is possible a few of cuvettes were contaminated in the vicinity of the liquid.The service engineer suspected that the liquid could have come from the reagent syringe assembly so it was replaced.Following service thcg was recalibrated, quality control (qc) was in range and no leaks have been identified.The customer is operational and requires no further support.No potential product issue is observed.The customer is operational.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG (THCG) ASSAY
• Type of Device: TOTAL HCG (THCG) ASSAY
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16543951
• MDR Text Key: 311381322
• Report Number: 1219913-2023-00049
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female