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

Model Number	PTH
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).
Event or Problem Description
The initial reporter stated they received questionable results for samples from one patient tested with the elecsys pth assay and compared to a competitor method.The elecsys pth results did not agree with the patient¿s clinical picture and the customer suspects an interference in the patient sample affecting the elecsys pth results.On (b)(6) 2023, a sample from the patient had an elecsys pth value of 2657.0 pg/ml.On (b)(6) 2023, a sample from the patient had an elecsys pth value of 2849.0 pg/ml.At an unknown date, a sample from the patient had a pth competitor value of 53.2 ng/l (reference range 18.4-80.1 ng/ml).It was asked but it is unknown which sample was used for this measurement.
Additional Manufacturer Narrative
Quality control results were stable and do not indicate an issue.The sample is not available for further investigation.Based on the available data and information there is no hint for a generic reagent issue.The investigation could not identify a product problem.The cause of the event could not be determined.The data is consistent to an interference in the sample (e.G.Heterophilic antibodies against assay antibodies) leading to high signals and thus to the high results.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17337644
• Report Number: 1823260-2023-02315
• Device Sequence Number: 15356986
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/26/2023

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: 12/31/2023
• Device Model Number: PTH
• Device Catalogue Number: 07251068190
• Device Lot Number: 64624601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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