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

Catalog Number ASKU

Device Problem Low Test Results (2458)

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

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received questionable results for one patient sample tested for multiple assays on the cobas 6000 e 601 module (e601).Of the questioned results, there were erroneous results for the following assays: elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), the elecsys tsh assay (tsh), the elecsys myoglobin immunoassay (myo), elecsys ferritin (ferr), the elecsys free psa immunoassay (fpsa), and the elecsys cortisol test system (cort).It was asked, but it is not known if the erroneous results were reported outside of the laboratory.Roche markets the following myo assays: elecsys myoglobin immunoassay and elecsys myoglobin stat immunoassay.It was asked, but it is not known which myo assay was used for sample testing.Roche markets the following cort assays: elecsys cortisol test system and elecsys cortisol ii.It was asked, but it is not known which cort assay was used for sample testing.The sample was collected on (b)(6) 2017 and tested on the e601 and abbott analyzers on (b)(6) 2017.The customer believes that the sample may contain an interferent which interferes with the roche assays.Refer to the attachment for all sample data.An additional myo value of 21.30 ug/ml was provided.It could not be clarified if this was an additional myo value from the patient sample, or if it was provided in error.A clarification has been requested.The cort results were measured after one freeze/thaw cycle of the sample.This medwatch will apply to the cort assay.Refer to the following manufacturer report reference numbers for information related to the ft3, ft4, and tsh assays: 1823260-2017-00142-00 = ft3, 1823260-2017-00143-00 = ft4, 1823260-2017-00144-00 = tsh.Refer to the medwatches with the following patient identifiers for information related to the myo, ferr, and fpsa assays: (b)(6) = cort, (b)(6) = ferr, (b)(6) = fpsa.No adverse events were alleged to have occurred with the patient.The serial number of the e601 analyzer used at the customer site was (b)(4).

Manufacturer Narrative

The patient has hypertension, type 2 diabetes, asthma, and gout.

Manufacturer Narrative

It has been confirmed that the myo value of 21.30 ug/ml was provided in error.Samples from the patient were provided for investigation.The samples were found to contain an interfering factor to the streptavidin used in the roche assays.This limitation is covered in product labeling.

• Brand Name: ELECSYS CORTISOL TEST SYSTEM
• 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: 6776735
• MDR Text Key: 82709366
• Report Number: 1823260-2017-01653
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• 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: 07/13/2017
• 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: 67 YR