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

Model Number	PTH
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for four samples collected from the same patient and tested with the elecsys pth immunoassay on a cobas 8000 e 801 module (serial number (b)(4)).The results did not agree with the patient's clinical status.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The first sample resulted in a pth value of 462 pg/ml when tested on the e 801 analyzer on (b)(6) 2022.The second sample resulted in a pth value of 440 pg/ml when tested on the e 801 analyzer on (b)(6) 2022.The third sample resulted in a pth value of 415 pg/ml when tested on the e 801 analyzer on (b)(6) 2022.This sample was treated with polyethylene glycol (peg) and repeated on the e 801 analyzer on (b)(6) 2022, resulting in a raw value of 17.5 pg/ml, which calculated to a final value of 35 pg/ml (8.4 % recovery) when accounting for the dilution factor.The fourth sample resulted in a pth value of 404 pg/ml when tested on the e 801 analyzer on (b)(6) 2022.This sample was repeated on an architect analyzer, resulting in a pth value of 895.0 pg/ml on (b)(6) 2022.The patient had no clinically confirmed pathology related to the parathyroids.The patient has normal calcium and the parathyroids are normal in imaging studies.It is expected for the patient to have a normal pth value between 15 and 65 pg/ml.
Additional Manufacturer Narrative
The sample results were reported outside of the laboratory where they were questioned by a clinician since they did not match the patient's clinical status.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation.Initial investigations of the sample determined that it contains heterophilic antibodies which interfere with the assay.The specific type of interference is still trying to be determined.The investigation is ongoing.
Additional Manufacturer Narrative
Quality controls were acceptable.There was no indication of an instrument related issue.Further investigation of the patient sample determined it contains a heterophilic antibody interferent and an additional unknown interferent.No further investigations could be performed on the sample as the sample material was used up during testing.Additional sample material was provided by the customer for investigations.For investigation of this material, the sample was fractionated by size exclusion chromatography.Reactivity with elecysys pth and pth (1-84) kits is only found in fractions where there is a molecular weight of > 150 kda, which may correspond to igg bound to pth.The results show an autoantibody-based interfering factor in the patient's blood leading to a higher signal and consequently falsely elevated pth.The investigation could not identify a product problem.

• 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: 15885036
• Report Number: 1823260-2022-03805
• Device Sequence Number: 5102875
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup
• Report Date (Section B): 03/17/2023

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 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: 11/15/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 01/13/2023; 03/15/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/01/2022; 02/02/2023; 03/17/2023
• 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