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

Catalog Number	08928428190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable pth elecsys e2g results from the cobas e 801 module.One example was provided.The initial result was 14.4 pg/ml.The repeat results were 56.1 pg/ml and 56.6 pg/ml.
Additional Manufacturer Narrative
D4 expiration date was updated.The investigation is ongoing.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.A general reagent or analyzer problem was not present, as the provided calibration and qc data were acceptable.The analyzer alarm trace contained numerous sample-quality-related alarms, indicating possible preanalytic issues.There was no product problem identified.

• 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: 23073242
• Report Number: 1823260-2025-02979
• Device Sequence Number: 15951769
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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,Followup
• Report Date (Section B): 11/21/2025

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: 06/30/2026
• 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): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 11/07/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/06/2025; 11/21/2025
• 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