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

Model Number	PTH
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient samples were requested for investigation.(b)(6).
Event or Problem Description
The initial reporter stated they received questionable results for two 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 were reported outside of the laboratory and questioned by the clinician.The value was expected to be very low as the patient no longer has a parathyroid gland.The first sample resulted in a pth value of 949.00 ng/l when tested on the e 801 module.The second sample resulted in a pth value of 931.00 ng/l when tested on the e 801 module on (b)(6) 2022.This sample was also tested on an abbott alinity ci-series analyzer, resulting in a pth value of < 4.0 pg/ml on (b)(6) 2022.
Additional Manufacturer Narrative
Calibration and control data showed no indication of a reagent issue.A sample from the patient was provided for investigation.The investigation showed the sample contained heterophilic antibodies which interfered with the assay components, leading to implausibly high pth values.Further investigations of the sample with a heterophilic blocking tube indicated 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." 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14142965
• Report Number: 1823260-2022-01106
• Device Sequence Number: 4142537
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/31/2022

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: 04/30/2022
• Device Model Number: PTH
• Device Catalogue Number: 07251068190
• Device Lot Number: 50767501
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/31/2022
• 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