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	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 402 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable pth elecsys e2g 300 results from two patient samples tested on the cobas e 402 analytical unit.Patient sample 1: the initial result was 10.8 pg/ml.The repeat result was 37.8 pg/ml.Patient sample 2: the initial result was 13.7 pg/ml.The repeat result was 44.9 pg/ml.The initial results were not reported outside of the laboratory.The initial results were deemed low, prompting the reruns.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the calibration results were within the specified ranges.The qc results were within the specified ranges.The alarm trace did not indicate any issues.The customer used 12 mm tubes.Product labeling states: "specifications of standard containers: sample tubes - 16 mm × 100 mm , 16 mm × 75 mm, 13 mm × 100 mm, 13 mm × 75 mm" the field service engineer (fse) inspected the analyzer and found white liquid in the measurement circuit, which is consistent with a procell system reagent contamination.He performed preventive maintenance, including probe adjustments, decontamination, and instrument checks.A general reagent or analyzer problem was not present, because the qc before the event was within ranges the investigation determined the event was consistent with the customer's use of incorrect sample tubes and contamination of the procell system reagent.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: 23060874
• Report Number: 1823260-2025-02899
• Device Sequence Number: 10044542
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 10/10/2025

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: 08/22/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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