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

Catalog Number	08928428190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable pth elecsys e2g 300 result from two of the cobas e 801 analytical units for one patient.The initial result from the cobas e 801 analyzer unit a was 65.3 pg/ml, and the repeat result on the cobas e 801 analyzer unit b was 84.9 pg/ml.The initial result was repeated because a doctor questioned them.The repeat result was deemed to be correct.The result from another hospital was 61.0 pg/ml.
Additional Manufacturer Narrative
The cobas e 801 analytical unit a serial number is (b)(6).The cobas e 801 analytical unit b serial number is (b)(6).The customer reported that qc was okay before the event.The customer stated that the issue was resolved by loading fresh packs and completing calibration.They also ran a 21-cup precision test and a correlation study.The precision, mean, and correlation study were all acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The customer reported that they determined that the application hadn't been calibrated since july.They loaded a new pack and got a new lot of calibration.The customer verified that there have not been any new events.Per the product labeling, "renewed calibration is recommended as follows: every 12 weeks when using the same reagent lot every 28 days when using the same cobas e pack on the analyzer." the investigation determined that the root cause was customer education on proper product 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23303363
• Report Number: 1823260-2025-04205
• Device Sequence Number: 16000771
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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