MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number	07251068190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pth reagent expiration date was not provided.The cobas pro ssu analyzer serial number was (b)(6).The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested for elecsys parathyroid hormone (pth) assay on a cobas pro ssu analyzer.Initial result: 455 pg/ml (tested on the customer's e801 analyzer).Two other tubes were drawn from the patient at the same time: tube 2 and tube 3.The customer provided tube 2 and tube 3 for investigation, where they were tested on 13-may-2025 on a 2nd e801 analyzer: tube 2 results were 332 pg/ml and 325 pg/ml.Tube 3 result was 321 pg/ml.On 14-may-2025, tube 2 was also repeated on e801 at the investigation site, and the repeat result was 319 pg/ml.
Additional Manufacturer Narrative
Two samples from the same patient were received for investigation.The qc was within the specified range.The two samples were measured with pth epack and pth 1-84 epack tests on a cobas e801 analyzer.The samples were measured with and without heterophilic blocking tube (hbt) treatment, resulting in the following: (b)(6): pth: 309 pg/ml.Pth 1-84: 29.2 pg/ml.(b)(6): with hbt treatment: pth: 22.6 pg/ml.Pth 1-84: 26.3 pg/ml.(b)(6): pth: 308 pg/ml.Pth 1-84: 29.6 pg/ml.(b)(6) with hbt treatment: pth: 23.3 pg/ml.Pth 1-84: 26.8 pg/ml.Treatment with hb tubes had a clear effect on the pth results in both samples.If the result from the hbt-treated sample is significantly lower than the original result, it indicates that heterophilic antibodies were present and caused a false reading.The pth (1-84) assay is not affected.The product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The reagent meets the specifications.The cause of the event was due to an interfering factor.

• Brand Name: ELECSYS PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22160779
• Report Number: 1823260-2025-01758
• Device Sequence Number: 7484750
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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 Catalogue Number: 07251068190
• Device Lot Number: 801714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown