MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM INTACT PARATHYROID HORMONE (PTH); RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The customer reported an observation of discordant elevated intact parathyroid hormone (pth) results on multiple patient(s) samples on atellica im 1600 analyzer.The initial results were reported to the physician(s), who did not question the results.All the samples were repeated on alternate atellica im 1600 analyzers and the results were lower compared to the initial results.These results were considered as correct results by the physician(s).A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to this issue.

Manufacturer Narrative

A customer from outside the united states reported an observation of discordant elevated intact parathyroid hormone (pth) results on multiple patient(s) samples on atellica im 1600 analyzer.The initial results were reported to the physician(s), who did not question the results.All the samples were repeated on alternate atellica im 1600 analyzers and the results were lower compared to the initial results.These results were considered as correct results by the physician(s).A corrected report was issued.Siemens reviewed the calibration and identified that quality control results were outside established ranges.Customer proceeded to report the patient samples despite qc failure.The interpretation of results section of the atellica im intact parathyroid hormone (pth) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is evaluating.A separate mdr was filed for a different date of testing for the same issue.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2024-00006 on 17-jan-2024.Additional information on 24-jan-2024: a customer from outside the united states reported an observation of discordant elevated intact parathyroid hormone (pth) results on multiple patient(s) samples on atellica im 1600 analyzer.The initial results were reported to the physician(s), who did not question the results.On (b)(6) 2023, the customer loaded and calibrated atellica im pth reagent lot 096 on atellica im sn# (b)(6).The calibration was valid although the recovery was low and quality control (qc) with this calibration recovered high and out of insert ranges.Several patient samples were processed with this calibration and needed to be corrected.The calibration, qc and discordant samples used the same reagent pack.These samples were repeated on alternate atellica im analyzers, which produced lower results compared to the initial results.The lower values obtained were deemed correct by the customer.Atellica im sn# (b)(6) was recalibrated with another reagent pack of pth lot 096 and the calibration and controls were acceptable.Based on the available information, the cause of the elevated qc and patient results is consistent with an isolated reagent handling issue.The customer is operational and continues to use pth reagent lot 096 without further concern.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2024-00005 supplemental 1 was filed for a different date of testing for the same updates.

• Brand Name: ATELLICA IM INTACT PARATHYROID HORMONE (PTH)
• Type of Device: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18530121
• MDR Text Key: 333348574
• Report Number: 1219913-2024-00006
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 00630414599458
• UDI-Public: 00630414599458
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K163658
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10995622
• Device Lot Number: 096
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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