MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CORTISOL; ENZYME IMMUNOASSAY, CORTISOL, SALIVARY

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for free triiodothyronine (ft3), free thyroxine (ft4), and cortisol on an e601 analyzer.The patient's ft4 value was said to be implausible and was not fitting the patient's clinical history.The patient had no clinical symptoms of hyperthyreosis.The patient's cortisol result was said to be implausible.There were no error messages on the analyzer.It was stated that the patient sample behaved strangely with almost all applied elecsys assays.This medwatch will cover the cortisol assay.Please refer to the medwatch with (b)(6) for information related to the ft3 assay and the medwatch with (b)(6) for information related to ft4.The patient sample initially resulted as 16.54 pmol/l for ft3, > 100 pmol/l for ft4, and 1610 nmol/l for cortisol.The initial values were reported outside of the laboratory.The doctor did not trust the initial values, so he requested repeat analysis of the sample with assays from a different manufacturer.The sample was repeated on a siemens vista analyzer, resulting as 7.56 pmol/l for ft3, > 100 pmol/l for ft4, and 1441 nmol/l for cortisol.The customer also stated that the ft4 value was unchanged after blocking the "heterophile ak".The patient was not adversely affected.The e601 analyzer serial number was (b)(4).The patient sample was provided for investigation.During investigation of the sample, the ft3, ft4, and cortisol values obtained by the customer could be confirmed.Further investigations of the sample did not detect any interfering factors within the sample.For the differences seen in the ft3 results, different assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, the differences in reference materials/methods, and the standardization methodology used.A general reagent issue at customer site most likely can be excluded.

• Brand Name: CORTISOL
• Type of Device: ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
• 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: 5815040
• MDR Text Key: 50186831
• Report Number: 1823260-2016-01034
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K070788
• 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
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 189893
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/22/2016
• 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: 23 YR