MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number	07251068190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
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 and a cobas e 602 module.Over a long period of monitoring, the patient has had a pth concentration in the normal reference range of 15 - 65 pg/ml.The sample resulted in pth values of 25.1 pg/ml, 24.4 pg/ml, 25.9 pg/ml, and 19.9 pg/ml when tested on the e 801 analyzer.The sample was treated with a 25% polyethylene glycol (peg) solution in a 1:1 ratio, resulting in pth values of 40.2 pg/ml (160.16 % recovery) and 51.8 pg/ml on the e 801 analyzer.The sample was diluted 1:2 and tested on the e801 system, resulting in a raw pth value of 9.34 pg/ml which calculated to a final value of 18.68 pg/ml when accounting for the dilution factor.The sample was diluted 1:4 and tested on the e801 system, resulting in a raw pth value of 5.85 pg/ml which calculated to a final value of 23.4 pg/ml when accounting for the dilution factor.The sample was diluted 1:8 and tested on the e801 system, resulting in a raw pth value of 5.68 pg/ml which calculated to a final value of 45.44 pg/ml when accounting for the dilution factor.The sample was diluted 1:16 and tested on the e801 system, resulting in a raw pth value of 7.35 pg/ml which calculated to a final value of 117.6 pg/ml when accounting for the dilution factor.An additional e 801 pth value from the sample was provided as 6.17 pg/ml, but it is not known if this value was obtained upon dilution of the sample or with peg treatment.Additional repeat testing of the sample performed on the e 801 analyzer showed good repeatability.No additional data was provided.The sample was tested on an e 602 analyzer at a second site, resulting in a pth value of 20.8 pg/ml.The patient sample was tested on an abbott device, resulting in a pth value of 94.9 pg/ml.The sample was also treated with a 25 % peg solution at a 1:1 ratio and repeated on the abbott device, resulting in a pth value of 34.9 pg/ml (36.78 % recovery).
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is(b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The abbott measurements and the e 801 analyzer measurement of 40.2 pg/ml with the peg treated sample were performed the next day.A review of quality control data showed stable recovery.There was no indication of a reagent issue.A clear root cause could not be identified because there was no remaining sample from the patient available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• 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: 23632039
• Report Number: 1823260-2025-04802
• Device Sequence Number: 18464207
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• 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): 12/10/2025

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 Catalogue Number: 07251068190
• Device Lot Number: 853379
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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