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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that the values obtained with a roche instrument for one sample tested for the following tests did not fit the clinical picture of the patient: testosterone (testo), dehydroepiandrosterone sulfate (dhea-s), antibodies to tsh receptor (anti-tshr), free triiodothyronine (ft3), free thyroxine (ft4), and thyrotropin (tsh).Testo, dhea-s, anti-tshr, ft3, and ft4 values were said to be very high.The tsh value was said to be normal.The sample was tested for anti-tpo and anti-thyroglobulin using the liaison testing method and the results for these tests were positive.The sample was also tested for androstanediol glucuronide and androstenedione using a ria testing method and results from these tests were normal.The results obtained with the roche methods and other methods were said to not fit with each other.All results were sent to the physician.The customer also mentioned that another sample was collected from the patient in the same year and tested for the same tests using the roche method at a different laboratory and these results were similar to the sample in question.No specific result values were provided for any of the questioned samples.This medwatch will cover testo.Refer to the medwatches with patient identifier (b)(6) for information related to ft3, patient identifier (b)(6) for information related to ft4, patient identifier (b)(6) for information related to tsh, patient identifier (b)(6) for information related to dhea-s, and patient identifier (b)(6) for information related to anti-tshr.The patient was not adversely affected.The analyzer model and serial number used for testing was asked for, but not provided.

Manufacturer Narrative

The customer has provided the patient data.Including relevant test data.Data was provided for samples from the same patient tested on (b)(6) 2013, (b)(6) 2015, and for the complained sample tested on (b)(6) 2015.In the attachment, the ft3 test is referred to as "t3 libre", ft4 is referred to as "t4 libre", anti-tshr is referred to as "anti-thyroglobuline", testo is referred to as "testosterone totale", and dhea-s is referred to as "dhea sulfate".

Manufacturer Narrative

The customer provided data for a new sample that was tested from the patient on 01/28/2016.The sample was said to have similar values to previous samples.(b)(4).In the attachment, the ft3 test is referred to as "t3 libre", ft4 is referred to as "t4 libre", anti-tshr is referred to as "anti-thyroglobuline", testo is referred to as "testosterone totale", and dhea-s is referred to as "dhea sulfate".The patient was not suffering from a known renal insufficiency, a known liver insufficiency, or a known malignant disease.The patient was not pregnant.(b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigation of the sample determined that it contains an interfering factor to streptavidin.This interfering factor caused the result difference seen with the testosterone assay.This limitation is covered in product labeling.

• Brand Name: ELECSYS TESTOSTERONE II IMMUNOASSAY
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• 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: 5355219
• MDR Text Key: 35494536
• Report Number: 1823260-2016-00019
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR