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

Catalog Number 07027915190

Device Problem High Test Results (2457)

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

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable high elecsys testosterone ii assay result for one patient sample.The result from the cobas 8000 e 801 module serial number (b)(4) was 12.60 nmol/l and the repeat result on (b)(6) 2017 was 11.90 nmol/l.The sample was sent to another laboratory for testing by lc-ms/ms and the testosterone result was 0.4 nmol/l.The results were reported to the clinician.There was no allegation of an adverse event.The customer suspected the medications taken by the patient were causing interference.

Manufacturer Narrative

A specific root cause could not be identified as no sample material was available for further investigation.Per product labeling, there is cross-reactivity with norgestrel ( levonorgestrel).Since they all have a steroid structure, cross-reactivity could be possible with the corticosteroid and the contraceptive pill.Cross-reactivity with terbutaline would not be likely.Review of the provided calibration, qc, and analyzer data did not indicate any issues with the reagent or instrument.

• 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: 7003096
• MDR Text Key: 92174720
• Report Number: 1823260-2017-02537
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027915190
• Device Lot Number: 23298000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• 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: 22 YR