MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR TOTAL HCG; TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) ASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 03/18/2023

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer observed an elevated total human chorionic gonadotropin (thcg) result on a female patient, on advia centaur xp (lot 343).After re-centrifugation, the sample was repeated on the same advia centaur xp which also gave a high result relatively.The same sample was repeated on two alternate methods and the results were similar to the advia centaur xp repeat result.A different sample from the same patient was repeated on the advia centaur xp and alternate method 1, which gave lower results when compared to the initial result.On (b)(6) 2023, a new sample was collected from the same patient, which was processed only on alternate method 1, as the advia centaur xp reagent ran out.This result was considered as correct by the physician(s).The calibration of the thcg was verified and it is within the acceptability criteria.Immunoassay plus controls, lot 40420, close to average at 3 levels on (b)(6) 2023.The customer informs that an investigation is open with the bd manufacturer of the collection tube.Tube with clot activator and separating gel.The interpretation of results section of the advia centaur thcg instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer observed an elevated total human chorionic gonadotropin (thcg) result on a female patient, on advia centaur xp (lot 343).The initial result was not reported to the physician(s).After re-centrifugation, the sample was repeated on the same advia centaur xp which also gave a high result relatively.The same sample was repeated on two alternate methods and the results were similar to the advia centaur xp repeat result.A different sample from the same patient was repeated on the advia centaur xp and alternate method 1, which gave lower results when compared to the initial result.On (b)(6) 2023, a new sample was collected from the same patient, which was processed only on alternate method 1, as the advia centaur xp reagent ran out.This result was considered as correct by the physician(s).There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the discordant advia centaur thcg results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00079 on apr 10, 2023.Additional information may 22, 2023: the customer observed an elevated total human chorionic gonadotropin (thcg) result on a female patient, on advia centaur xp (lot 343).After re-centrifugation, the sample was repeated on the same advia centaur xp which also gave a high result relatively.The same sample was repeated on two alternate methods and the results were similar to the advia centaur xp repeat result.A different sample from the same patient was repeated on the advia centaur xp and alternate method 1, which gave lower results when compared to the initial result.On (b)(6) 2023, a new sample was collected from the same patient, which was processed only on alternate method 1, as the advia centaur xp reagent ran out.This result was considered as correct by the physician(s).Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Based on the available information, the cause of the discordant results is consistent with a preanalytical issue with the first sample drawn.Return of the patient sample for further investigation is not warranted because the discordant results were not reproducible.A potential product performance issue has not been identified.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR TOTAL HCG
• Type of Device: TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: 16706453
• MDR Text Key: 312940561
• Report Number: 1219913-2023-00079
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K200210
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: 17 YR
• Patient Sex: Female