MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY; PTH IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The high results were reported on (b)(6).The quality control and calibrations were checked and were acceptable.All the results were from the same reagent pack.All the repeated samples were using the same tube.A field service engineer (fse) was dispatched to the custmer site.Awaiting the details of the fse report to be provided.Siemens healthcare diagnostics is awaiting further information.The interpretation of results of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states: "interpretation of intact pth values should always take into account serum calcium results and the interrelationship between these 2 elements in various disorders involving pth and calcium.It is recommended that the intact pth results should always be interpreted with caution and with consideration of the overall clinical manifestations even when used in conjunction with calcium values." mdr 1219913-2019-00081 was filed for the same event.
Event or Problem Description
Discordant high advia centaur xp intact parathyroid hormone (pth) results were obtained for a "big amount" of patient samples.The results were higher than expected.The samples were repeated, and the results were lower.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences as a result of the discordant pth result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00094 on may 22, 2019.05/30/2019 additional information: details of the field service engineer (fse) report were received and the following was performed: 05/072019, calibration and check.Proper functioning.Quality control and samples processed.All ok.05/15/2019, the following were changed: acid and wash1 lid sensors.Bulk reservoir wash1.4 pinch valve wash1.Qc and samples processed.All ok.05/21/2019, the following intervention changed: wash1 reservoir, s1 and s2 sensors from wash1.Exchange the pinch valve of the wash1 cap for acid.Pcb interconnection card.Qc and samples processed.All ok.05/22/2019, last intervention changed: s1 and s2 of wash1 were replaced because the previous sensors that were changed did not work.Qc and samples processed.All ok.06/07/2019: the customer reported high discordant patient results on the intact parathyroid hormone (pth) assay on the advia centaur xp with reagent lot 021.The customer reported no other assays were impacted.It was noted by the customer that the wash 1 was depleted from the reservoir.The customer runs other assays, however the pth assay is the only one that uses wash 1.The region indicated the issue was resolved post fse visit as routine troubleshooting.The customer satisfied with system and assay performance.There is no evidence of a product nonconformance.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00081 supplemental report 1 was filed for the same event.

• Brand Name: ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY
• Common Device Name: PTH IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8632787
• Report Number: 1219913-2019-00094
• Device Sequence Number: 19337170
• Product Code: CEW
• UDI-Device Identifier: 00630414592336
• UDI-Public: 00630414592336
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K163658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 12/05/2019
• Device Model Number: N/A
• Device Catalogue Number: 10699154
• Device Lot Number: 24274021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1