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	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys pth assay on a cobas e 801 module, serial number (b)(6), and compared to a competitor method.The sample was collected on (b)(6) 2023 and initially resulted in a pth value of 405 pg/ml.The sample was then repeated using the wako accuraseed method, resulting in a pth value of 56 pg/ml.The sample was provided for investigation where it was tested with the elecsys pth assay on a cobas e 801 module on (b)(6) 2023 resulting in a pth value of 405 pg/ml.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
H3 other text : na.
Additional Manufacturer Narrative
Medwatch field b7 was updated.
Additional Manufacturer Narrative
Additional data, generated during the first investigations of the sample was provided.The sample was treated with a heterophilic blocking tube (hbt) resulting in the following elecsys pth results.Before hbt sample treatment the pth result was 405 pg/ml.After hbt sample treatment, the pth results was 53.3 pg/ml (recovery 13%).The investigation is ongoing.
Additional Manufacturer Narrative
The sample was requested for further investigations but could not be provided.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a human anti-mouse antibody (hama) interference.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.".

• 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: 16919277
• Report Number: 1823260-2023-01607
• Device Sequence Number: 6805193
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/16/2023

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: ASKU
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 06/26/2023; 07/25/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/22/2023; 07/18/2023; 08/16/2023
• 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