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

Catalog Number 11875116122

Device Problem High Test Results (2457)

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

Event Date 03/03/2010

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the event occurred in: (b)(6).

Event Description

The customer complained that the results for 1 patient tested for elecsys cortisol test system and elecsys acth test system (acth) on a cobas 8000 e 602 module do not match the clinical picture for the patient.It is not known if the incorrect results were reported outside of the laboratory.This medwatch will cover cortisol.(b)(4).The patient was at the hospital as they were diagnosed with terminal chronic renal insufficiency and undergoing dialysis.A hormonal assessment was ordered on (b)(6) 2010 to explore the corticotropic axis.Acth was found to be weak while cortisol was high which was inconsistent with the clinical status.Specific results were not provided.The patient was then questioned and a biotin intake was found.Acth and cortisol testing was then performed with a different assay technique.Specific method used and specific results were not provided.The patient had biotin testing performed and the testing confirmed a high concentration of biotin in the body.The biotin result was greater than 160 nmol/l.No information is known about the current status of the patient.There was no allegation that an adverse event occurred.The cobas e602 serial number was not provided.

Manufacturer Narrative

Since there is no sample available to investigate and due to a general lack of information available, further investigation into the claim of a possible biotin interference is not possible.Product labeling for acth indicates the assay is unaffected by biotin levels up to 246 nmol/l.Product labeling for cortisol indicates the assay is unaffected by biotin levels up to 123 nmol/l.For both acth and cortisol testing, samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration.From the information provided a general reagent issue can most likely 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: 7168489
• MDR Text Key: 97074623
• Report Number: 1823260-2018-00079
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 11875116122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 01/25/2018
• 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: 55 YR