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	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample from the patient was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable low elecsys pth immunoassay results from cobas e801 module serial number (b)(4).The patient's pth was repeatedly measured in an interval of about 1 month.The result was always an implausibly low value that was less than the measuring range of the assay.One example was provided of a result from a beckman analyzer of 20.2 ng/l.The sample was frozen and one month later was tested on the cobas e801 with a result of <1.2 ng/l.The specific date of testing was not provided.The questionable results were reported outside of the laboratory.The results from the beckman analyzer were considered correct as they fit the clinical expectations of the medical doctor in charge (nephrologist).
Additional Manufacturer Narrative
Sample from the patient was received for investigation and was tested with the following results: pth elecsys e2g: 1.20 pg/ml with a data flag.Elecsys pth (1-84): 33.7 pg/ml.Elecsys pth (1-84) v2 biotin version: 9.70 pg/ml.Further investigations are ongoing.
Additional Manufacturer Narrative
Further investigation found an interfering factor against the streptavidin component of the reagent was present in the sample.Per product labeling for the assay "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
• 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: 12439009
• Report Number: 1823260-2021-02638
• Device Sequence Number: 11665861
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2021

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: 507675
• 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: 08/19/2021
• Supplement Date Received by Manufacturer: 09/06/2021; 12/06/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/01/2021; 12/17/2021
• 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 Age: 70 YR
• Patient Sex: Male