MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PTH ELECSYS E2G 300; PARATHYROID HORMONE ASSAY

Catalog Number	08928428190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable pth assay results for one patient sample tested on a cobas pro sbl e 801 analyzer.On (b)(6) 2025: the initial result was 90 ng/ml.On (b)(6) 2025: the sample was repeated at another laboratory, generating a result of 50.9 ng/ml using a different method.On (b)(6) 2025: further repeat testings were conducted at multiple laboratories with aliquots from the same blood sample; one laboratory reported 70 ng/ml, another reported 38 ng/ml, and another reported 50 ng/ml.It was indicated that the results did not align with the clinical history of the patient.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: PTH ELECSYS E2G 300
• Common Device Name: PARATHYROID HORMONE ASSAY
• 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: 22608507
• Report Number: 1823260-2025-02284
• Device Sequence Number: 10106065
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/22/2025

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: 08928428190
• Device Lot Number: 855897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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