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

Model Number	PTH
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys pth (pth) on a cobas e 801 module compared to the abbott method.On (b)(6) 2023 the initial result was 1.20 pg/ml.The customer repeated the sample on 2 different instruments in the laboratory and received the same result.On (b)(6) 2023 the customer sent the sample to another laboratory where the result from the abbott method was 20.2 pg/ml.It is not known if the questionable results were reported outside of the laboratory.The customer suspects an interference in the sample.The e801 module serial number was(b)(6).
Additional Manufacturer Narrative
The customer's elecsys pth result could be confirmed.Upon investigation of the sample, an interfering factor against streptavidin could be identified.Product labeling for the assay documents this interference: 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.

• 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: 17138143
• Report Number: 1823260-2023-01982
• Device Sequence Number: 17647543
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 07/18/2023

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: 06/30/2024
• Device Model Number: PTH
• Device Catalogue Number: 07251068190
• Device Lot Number: 70634601
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/18/2023
• 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