MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR INTACT PARATHYROID HORMONE (PTH); INTACT PTH ASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states obtained an elevated advia centaur intact parathyroid hormone (pth) result for one patient.The sample was repeated on an alternate advia centaur instrument, and the result was lower.The repeat result was considered as the correct result by the physician(s).Quality control was out of range.The interpretation of results section of the advia centaur intact parathyroid hormone (pth) 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 or Problem Description
The customer obtained an elevated advia centaur intact parathyroid hormone (pth) result for one patient.The sample was repeated on an alternate advia centaur instrument, and the result was lower.The repeat result was considered as the correct result by the physician(s).The initial result was reported to physician(s), who did not questioned the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant pth result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00030 on feb 13, 2023.Additional information feb 21, 2023: a customer from the united states obtained an elevated advia centaur intact parathyroid hormone (pth) result using lot 081 on one patient.The sample was repeated on an alternate advia centaur instrument, and the result was lower.The repeat result was considered as the correct result by the physician(s).Quality control was out of range.Siemens reviewed the instrument and event data including actions performed by the customer service engineer (cse).It was noted that the issue was resolved by putting new reagent packs on the system, calibrating with freshly made calibrator, and running fresh quality control.The region informed that troubleshooting was performed prior to arrival by field service, and no hardware troubleshooting was performed.All assays have been calibrated successfully, and qc was in range.The customer is satisfied, and no further troubleshooting support is requested.The system is now operational and fully functional.Siemens concluded that the probable cause of the discordant result was unable to be determined.While there is insufficient information to determine the cause of the erratic results, siemens cannot rule out pre-analytical factors, a sample issue, or a reagent shipping/handling issue.The issue was resolved with use of fresh reagent and calibrator as part of normal routine troubleshooting.No hardware/software product problem was identified for the advia centaur.The advia centaur system is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR INTACT PARATHYROID HORMONE (PTH)
• Common Device Name: INTACT PTH 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: 16363403
• Report Number: 1219913-2023-00030
• Device Sequence Number: 6756947
• Product Code: CEW
• UDI-Device Identifier: 00630414592336
• UDI-Public: 00630414592336
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K163658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 10699154
• Device Lot Number: 081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown