MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TESTOSTERONE II; RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Catalog Number 05200067190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/07/2015

Event Type  malfunction  

Event Description

The customer complained of erroneous results for 1 patient sample tested for testosterone (testosterone ii).The date of event was not provided.It is not known if erroneous results were reported outside of the laboratory.This information has been requested.This medwatch will cover reagent lot 178782.Refer to medwatch with patient identifier (b)(6) for information on reagent lot 183512.The initial 2 testosterone ii result was 1500 ng/dl with data flags which was repeated and confirmed.The sample was repeated by performing a manual 1:10 dilution and the result was 445 ng/dl.These 3 results were obtained with reagent lot 178782.The sample was repeated again by this same method and the result was 588 ng/dl with reagent lot 183512.The customer then performed a serial dilution with the sample and the following results were obtained: * 1:2 dilution result was 1667 ng/dl * 1:4 dilution result was 1218 ng/dl * 1:8 dilution result was 749.2 ng/dl * 1:16 dilution result was 446.7 ng/dl * 1:32 dilution result of 80 ng/dl (this result was 2.50 ng/dl with a data flag prior to multiplying by the dilution factor.) it is not known which reagent lot the serial dilution was performed with.This information has been requested.The sample was also sent to mass spectrophotometry and the result was 540 ng/dl.The customer believes this is the correct result.It is not known if the patient was adversely affected.This information was requested.The modular e module serial number was (b)(4).

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Date of event was clarified to be (b)(6) 2015.Clarification was received that erroneous results were not reported outside of the laboratory.Clarification was received that the serial dilutions were performed with reagent lot 178782.Clarification was received that the patient was not adversely affected.

Manufacturer Narrative

One sample was submitted for investigation and measured with reagent lot 178782.Undiluted tests were run and manually diluted tests were run.The customer's linearity results when performing dilution could be reproduced.

Manufacturer Narrative

During further investigation of the sample, measurements performed by liquid chromatography - mass spectrometry confirm that the testosterone ii value of the undiluted patient sample is high (> 150 ng/dl).Further investigation of the data provided by the customer indicates an interference in the patient sample.The interference may be caused by extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium.This is addressed in product labeling.

• Brand Name: TESTOSTERONE II
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4963125
• MDR Text Key: 6640364
• Report Number: 1823260-2015-03919
• 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,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• 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: 178782
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/07/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 075 YR