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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable pth elecsys e2g 300 results for 1 patient sample on a cobas e 801 msb/msbl module compared to a competitor analyzer.The customer questioned the initial result as it did not match the patient's clinical diagnosis, prompting them to repeat the sample.The roche result was 37.5 pg/ml.The competitor abbott result was 131.2 pg/ml.A 25% polyethylene glycol (peg) pretreatment was performed on the sample and retested in the roche analyzer, and the result was 74.8 pg/ml.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).An interfering factor is suspected in the patient sample.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The patient sample was received for investigation.No interfering factor against the assay components was detected.Comparative measurements were also performed suing roche and competitor assays which produced reproducible and comparable results.No product problem was 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: 24239357
• Report Number: 1823260-2026-00350
• Device Sequence Number: 13006933
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/13/2026

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: 85589702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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