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

Model Number	PTH
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys pth results for one patient tested with a cobas 8000 e 801 module.It was reported the pth calibration and qc results were acceptable.The patient's initial elecsys pth result was reported outside the laboratory.The patient's physician questioned the reported result and expected the pth result to be higher based on the patient's clinical picture.It was reported the patient's sample was also tested with the siemens centaur assay and the ortho vitros assay.Allegedly the elecsys and siemens results were below the reference interval, which was unexpected.The ortho vitros produced an elevated result.The specific pth results from the siemens centaur assay and the ortho vitros assay were requested but not provided.The patient's initial elecsys pth result was 8.3 pg/ml.The e 801 module serial number was unspecified.The patient had a new sample collected and the elecsys pth result was 7.22 pg/ml.The e 801 module serial number was (b)(4).The patient's elecsys pth result with a 1:2 dilution was 10.6 pg/ml.The e 801 module serial number was unspecified.The patient's elecsys pth result with a 1:3 dilution was 16.17 pg/ml.The e 801 module serial number was (b)(4).
Additional Manufacturer Narrative
The customer reported that no other samples have been affected.The customer declined a visit from the field service engineer.The customer reported the patient's samples were available, but little sample volume was left.The investigation reviewed the calibration and qc results and the results were acceptable on the date of the event.Further information surrounding the event was requested but not provided.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
Sections a2, a3, and d4 were updated.The patient has a history of hypercalcemia and hypophosphatemia.It was previously reported that the scantibodies-treated sample result, using the roche assay, from 21-jun-2022 was 6.7 pg/ml, but the updated result is 6.37 pg/ml.On 23-jun-2022, the patient's result with the ortho vitros ipth platform was 72.2 pg/ml and the scantibodies-treated result was 55.1 pg/ml.On 23-jun-2022, the patient's result with the siemens centaur platform was 7.6 pg/ml and the scantibodies-treated result was 6.2 pg/ml.Previous patient results were provided: in 2008, the patient's pth result was elevated at 85.1 pg/ml using a roche assay.A specific date was not provided.From 2009 to 2018, the patient's pth results were within the reference interval, but with a falling trend over the years: 30.6, 41.6, 40.7, 35.7, 37.1, 35.5, 28.6, 20.2 pg/ml.Specific dates or platforms used for the results were not provided.In 2020 to present, the patient's pth has been below the reference interval and ranged from 8.2 pg/ml to 10.5 pg/ml.Specific dates or platforms used for the results were not provided.On 05-apr-2021 a sample result with roche platform was 10.5 pg/ml and was 48.5 pg/ml at another laboratory using the ortho vitros ipth platform.On 29-apr-2021 a sample result with acl siemens platform was 9 pg/ml.The laboratory's reference interval for the roche assay is 15-72 pg/ml.The laboratory's reference interval for the ortho vitros ipth platform is 7.5-53.5 pg/ml.The laboratory's reference interval for the siemens centaur platform is 19-88 pg/ml.
Additional Manufacturer Narrative
A sample from the patient was requested for an investigation, but no sample material could be sent.No further investigation was possible.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation.Initial investigations of the sample were able to reproduce the results obtained by the customer.Investigations are ongoing.
Additional Manufacturer Narrative
Further investigations of the provided patient sample could exclude the following interferences: biotin, anti-streptavidin antibodies, and anti-ruthenium antibodies.Additional sample material from the patient was requested, but could not be provided.The customer provided additional data for previous testing of the patient.Refer to the attached data.
Additional Manufacturer Narrative
The sample was sent to an external laboratory for testing by the abbott alinity i intact pth assay with a result of 43.8 pg/ml.The result obtained is above the expected values for healthy individuals (expected values: 15.0 - 68.3 pg/ml).The investigation is ongoing.
Additional Manufacturer Narrative
Based on the provided information, a general reagent issue can most likely be excluded.The following interfering factors could not be confirmed in the patient sample: high doses of biotin, anti-streptavidin antibody, and anti-ruthenium antibody.No remaining patient sample was left for further measurements to be carried out.The investigation could not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
There was no additional sample volume left for further investigations.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15086986
• Report Number: 1823260-2022-02161
• Device Sequence Number: 17173574
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 617504
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 09/01/2022; 10/25/2022; 12/06/2022; 02/21/2023; 03/08/2023; 05/16/2023; 06/23/2023
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/22/2022; 09/26/2022; 11/11/2022; 12/22/2022; 02/23/2023; 03/17/2023; 06/09/2023; 07/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLUTICASONE PROPIONATE 50 MCG/ACT - 2X/DAY.; ROSUVASTATIN 10 MG - 1X/DAY.; VALSARTAN 160 MG - 1X/DAY.
• Patient Age: 53 YR
• Patient Sex: Female