MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TOTAL HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing.It is noted that the patient had demonstrated a lower result in previous testing.No other issues were identified, and the customer is operational.The interpretation of results section of the atellica im thcg 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 is investigating.

Event Description

The customer reports observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing.Thcg reagent lot 349 was in use at the time.An initial elevated thcg result was obtained, and identified as discordant relative to other clinical indications.The test was repeated twice using the same sample and instrument, and lower results were produced.The lower results were accepted as correct, and the patient¿s result report was corrected.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

Manufacturer Narrative

Mdr 1219913-2023-00293 was initially submitted on 2023-11-17.A customer from the united states reported observation of an elevated advia centaur total hcg (thcg) result which was discordant relative to repeat testing.The results were expressed in "u/ml".On 2023-11-20, clarification was received from the customer, correcting the result units to "miu/ml" (100-fold different).Following the correction of the result units, the incident is evaluated not to represent a potential for serious injury.No injury was reported, and no potential is identified in the observed result difference.The event is retrospectively assessed as not reportable.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated according to the updated information.Advia centaur total hcg results had been incorrectly expressed in the wrong units when the event was initially reported.Later information corrected the result units to miu/ml, modifying the incident evaluation.Section b6 has been updated with corrected data.

• Brand Name: ADVIA CENTAUR TOTAL HCG
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18161321
• MDR Text Key: 328419129
• Report Number: 1219913-2023-00293
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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