MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TESTOSTERONE G2; RADIOIMMUNOASSAY, TESTOSTERONE

Catalog Number 05200067190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable high elecsys testosterone ii assay results for one patient sample from cobas e 411 immunoassay analyzer serial number (b)(4).Sample 1 was drawn (b)(6) 2017 and the initial result on (b)(6) 2017 was 531.60 ng/dl.This result was reported to the patient who told the laboratory she did not have a previous high result.On (b)(6) 2017, the repeat result on the same analyzer was 472.70 ng/dl.An aliquot was sent to another laboratory and the result was 35 ng/dl (clia method).A second sample drawn from the patient on (b)(6) 2017 was tested at another laboratory (unknown method) and the result was 60 ng/dl.There was no allegation of an adverse event.The field service representative believed there was an interference related to the methodology and supplements taken by the patient.Review of the provided calibration and qc data did not suggest a reagent issue.

Manufacturer Narrative

A specific root cause could not be identified.The patient has fms.Gestrinone is similar to 19-norethisterone, which cross-reacts with the testosterone ii assay at ~6%.It is expected gestrinone would also exhibit some cross-reactivity.It is generally recommended not to measure steroid concentrations in patient under treatment with steroids.If steroids must be measured the results must be interpreted with caution.The investigation determined the difference in the results from the two methods was most likely caused by a cross-reactivity of gestrinone with the elecsys testosterone ii which appeared to not affect the clia assay.A true physiological change in hormone concentration could not be excluded.

• Brand Name: TESTOSTERONE G2
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONE
• 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: 7116446
• MDR Text Key: 95740161
• Report Number: 1823260-2017-02917
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05200067190
• Device Lot Number: 232994
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR