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

Catalog Number	07251068190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The patient sample was requested for investigation.
Event or Problem Description
The initial reporter received questionable elecsys pth results from one patient sample tested on the cobas e 801 analytical unit.The initial result from the analyzer was 451 pg/ml.This result was deemed elevated.The repeat result from a beckman i800 platform was 2.5 pmol/l.This result was within the normal range.The reporter performed a serial dilution: the repeat result at 2x dilution was 452 pg/ml.The repeat result at 4x dilution was 476 pg/ml.The repeat result at 8x dilution was 517.6 pg/ml.The repeat result at 16x dilution was 553.6 pg/ml.The repeat result at 32x dilution was 601.6 pg/ml the reporter noted that the serial dilution results had no dilution linearity.The reporter suspects a sample-specific interferent in the patient sample based on the clinical and laboratory findings.
Additional Manufacturer Narrative
The patient sample was received for investigation.The patient sample was tested for pth.The result confirmed the customer's result.The patient sample was tested for interferent using heterophilic antibody blocking tubes (hbt).The result confirmed the presence of a heterophilic antibody interferent in the patient's sample against the elecsys pth assay.The investigation determined that the interferent in the patient's sample (heterophilic antibodies) against assay components had caused the event.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.

• 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: 22902393
• Report Number: 1823260-2025-02625
• Device Sequence Number: 18414306
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/03/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 07251068190
• Device Lot Number: 839457
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Race: Asian