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	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).A review of the alarm trace data showed sample quality related alarms, including sample foam detection and abnormal sample aspiration alarms.The field service engineer determined the laboratory was experiencing water quality issues, which prompted a decontamination of the water system and instrument.A general reagent or analyzer issue was not present, because the qc prior to the event was within ranges.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys pth on a cobas e 801 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in a pth value of 4.47 pg/ml.The sample was repeated twice, resulting in pth values of 35.8 pg/ml and 36.3 pg/ml.
Additional Manufacturer Narrative
The customer provided data for two additional patient samples with discrepant pth results (samples 2 and 3).Sample 2 initially resulted in a pth value of 6.35 pg/ml on (b)(6) 2025.The sample was repeated twice, resulting in values of 79.8 pg/ml and 81.3 pg/ml on 26-jul-2025.Sample 3 initially resulted in a pth value of 5.07 pg/ml on (b)(6) 2025 and it repeated as 56.1 pg/ml on (b)(6) 2025.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 22665196
• Report Number: 1823260-2025-02353
• Device Sequence Number: 3825152
• 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): 09/24/2025

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: 816686
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/09/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/24/2025
• 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