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	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable pth elecsys e2g 300 results from the cobas e 801 analytical unit.Patient 1's initial result on (b)(6) 2025 was 7.30 pg/ml, and the repeat result on (b)(6) 2025 was 49.8 pg/ml.Patient 2's initial result on (b)(6) 2025 was 6.68 pg/ml, and the repeat result was 50.6 pg/ml.A new sample was collected and the results were 47.1 pg/ml and 48.3 pg/ml.The initial result was considered incorrect and was repeated because it was a low result.
Additional Manufacturer Narrative
The qc and calibration were passing at the time of the event.The customer is not following the recommended centrifugation and did not sufficiently invert the sample, as it was not inverted at all.The investigation determined that there was no product problem and that the root cause is consistent with poor pre-analytical handling.

• 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: 21949561
• Report Number: 1823260-2025-01363
• Device Sequence Number: 12851691
• 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
• Report Date (Section B): 06/13/2025

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: 816686
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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