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

Catalog Number	08928428190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable pth elecsys e2g 300 results for 1 patient on a cobas 8000 e 801 module.At 11:21 the result was 1060 pg/ml on analyzer a.At 16:48 the result was 1018 pg/ml on analyzer b.On (b)(6) 2025 a new sample was obtained and the result was 273 pg/ml.It is unknown which analyzer produced the result.The sample was repeated due to the results not fitting the patient's clinical picture.A drug-related interference is suspected.
Additional Manufacturer Narrative
The serial number for analyzer a is (b)(6) the serial number for analyzer b is (b)(6).The samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Two samples were received and investigated.Investigation results: the customer's very high results were confirmed during the investigation.The investigation did not find any interference in the samples that could result in implausibly high pth values.Therefore, the measured pth values obtained with the elecsys assays can be considered accurate.A general reagent issue was excluded.In general, the drug rituximab is considered very unlikely to interfere with the pth test (the test principle) because its specificity is not related to pth at all.However, an indirect interference (eg due to hama / heterophilic antibodies) cannot entirely be excluded: ritixumab is a chimeric mouse/human monoclonal antibody (mab) and theoretically, heterophilic antibodies against the murine regions in the antibody can be developed (hama).However, this is only speculation, and when a hama interference is detected, it is not known why the patient developed it.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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21232393
• Report Number: 1823260-2025-00227
• Device Sequence Number: 11834039
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/03/2025

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: 81668601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE (BESILATE); BENSERAZIDE; BISOPROLOL; CALCIUM DIACETATE; CHOLECALCIFEROL; CINACALCET (HCL); DOXAZOSIN (MESILATE); EPOETIN ALFA; IRON(III)(SODIUM D-GLUCONATE COMPLEX); LEVODOPA; METAMIZOLE SODIUM HYDRATE; MOXONIDINE; OMEPRAZOLE; PREDNISOLONE; RAMIPRIL; RITUXIMAB; SEVELAMER CARBONATE; SODIUM HYDROGEN CARBONATE; TACROLIMUS (HYDRATE); TORASEMIDE; ZINC BIS(HYDROGEN DL-ASPARTATE)
• Patient Sex: Unknown