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

Catalog Number	08928428190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number was (b)(6).The competitor method was siemens.The sample was requested for investigation.
Event or Problem Description
The initial reporter questioned low results not corresponding to the clinical picture for 1 patient sample tested for pth elecsys e2g 300 (pth) on a cobas 8000 e 801 module.The initial result was < 6 pg/ml with a data flag.The sample was repeated, and the result was < 6 pg/ml.A new sample was obtained and tested in a partner laboratory using a competitor method, and the result was 22 pg/ml.This result was believed to be correct.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Three samples from the patient were submitted for investigation.The samples were tested for pth and pth 1-84 on an e801 analyzer.Pth: the result for all 3 samples was < 6 pg/ml.Pth 1-84: the result for all 3 samples was < test.The samples underwent interference testing.No interference was identified.An aliquot of one of the samples was sent to an external laboratory using the abbott method.The pth result was 5.8 pg/ml.This result is below the 'normal' reference range of this assay of 18.4 - 80.1 pg/ml.Based on the investigation results, the low roche results are believed to be correct.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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21738717
• Report Number: 1823260-2025-00955
• Device Sequence Number: 15637188
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/11/2025

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: 01/31/2026
• Device Catalogue Number: 08928428190
• Device Lot Number: 81668601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White