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 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer obtained questionable high test results for an unspecified number of female patient samples using the elecsys testosterone ii assay on the cobas 8000 e 602 module (serial number (b)(4)).The customer states the issue has been going on "for some time", across multiple lots of reagent.The customer provided example data for two patient samples.It was unknown whether the initial results were released outside of the laboratory.No data flags or alarms occurred.The results are in units of nmol/l.Patient a: the initial result was 3.49; repeat result was 3.4.The sample was tested by mass spectroscopy with a result of 0.2.Patient b: the initial result was 4.1; repeat result was 1.02.The sample was tested by mass spectroscopy with a result of 0.8.There was no allegation that an adverse event occurred.The customer moved the reagent to another module on the analyzer and have had no further issues on the current module.The field service representative performed a high voltage adjustment, cell blank calibration, and deleted calibration data.He then conducted performance testing which passed.He cleaned the tubing in the pre-wash station and verified the adjustments.Investigation activities are ongoing.

Manufacturer Narrative

Patient b is a female with date of birth of (b)(6).It was clarified that all the results were released outside of the laboratory.The initial results were reported outside of the laboratory with a comment that the sample was sent for mass spectroscopy with a result to follow.Patient a had an additional repeat result from the e602 module of 4.3 nmol/l.Additional erroneous results for shbg were identified for patient a.On (b)(6) 2017 patient a had an initial shbg result of 60.89 (unit of measure not provided) on the e602 module.This result was reported outside of the laboratory.The repeat result from an external laboratory was 46 nmol/l.The actual initial testosterone result for patient b was 4.02 nmol/l and the repeat result was 4.1 nmol/l.Additional erroneous results for shbg were identified for patient b.On (b)(6) 2017 patient b had an initial shbg result of 132.2 (unit of measure not provided) on the e602 module.This result was reported outside of the laboratory.The repeat result from an external laboratory was 92 nmol/l.The customer provided additional erroneous testosterone results for a 3rd patient (patient c).Patient c is a (b)(6) year old female where the initial testosterone result was 3.2 nmol/l.This result was reported outside of the laboratory.The sample was repeated and the result was 3.25 nmol/l.The sample was tested by mass spectroscopy with a result of 0.7 nmol/l.It was noted that patient c is taking norethisterone which is known to interfere with testosterone results using this assay.This interference is addressed in product labeling.The customer stated the e602 module has no dust on it.

Manufacturer Narrative

A specific root cause was not identified.Calibration signals were within expectations.Quality control results also show outlier results.There is a possibility that there may be issues at the customer site with certain reagent kits recovering too high due to bubbles on the reagent.The instrument performance check data show borderline high and low results.Instrument conditions can contribute to inaccurate results.The results for patient a are unlikely related to an influence from medication since t4 and insulin are natural hormones present in any human.Since no patient samples can be provided, the investigation cannot be completed.

• 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: 6812737
• MDR Text Key: 83747834
• Report Number: 1823260-2017-01791
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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: 23299400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• 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: 19 YR