MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PTH ELECSYS E2G 300; 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	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.Two samples (from (b)(6) 2021) were sent for investigation and checked on cobas e 801 and cobas pro with pth reagent 507675.Results: sample (b)(6) 2021: 4.94 pg/ml sample (b)(6) 2021: 13.1 pg/ml the customer¿s low pth result for sample (b)(6) 2021 could be reproduced.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys pth immunoassay results for one patient sample with the cobas e 801 module (b)(4).The initial result was 6 pg/ml.This result was reproducible but considered clinically implausible for the patient according to the attending physician.The patient has been analyzed two times between (b)(6) 2021 and (b)(6) 2021 with low and decreasing pth values on the e 801.The original sample was re-analyzed on an abbott architect with a result of 27 pg/ml.This result was considered clinically plausible and correct.It is unknown if the questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The samples were sent to an external lab for testing by the siemens method and the following results were obtained: sample from (b)(6)-2021: 17.2 pg/ml sample from (b)(6)2021: 23.1 pg/ml the results are within the expected ranges for healthy subjects provided for this method (15.0 ¿ 68.3 pg/ml).The investigation confirmed an interference in the sample with elecsys pth assay, leading to lower results than expected.Product labeling states, "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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: PTH ELECSYS E2G 300
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12253457
• Report Number: 1823260-2021-02235
• Device Sequence Number: 14664489
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR