MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 11731459122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable thyroid results for one patient from a cobas 8000 e 602 module and tested the sample on an architect analyzer.The serial number of the cobas 8000 e 602 module and the specific date of testing was requested but was not provided.The sample was submitted for investigation and was tested on another cobas 8000 e 602 module analyzer and a cobas e 411 immunoassay analyzer.Of the data, the results for elecsys tsh assay and elecsys ft3 iii were discrepant.Refer to the attachment to the medwatch for all patient data.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.Information concerning if the erroneous results were reported outside the laboratory was requested, but it was unknown.The patient was not adversely affected.A specific root cause could not be determined.As no sample material remained, further investigation was not possible.From the information provided, a general reagent issue was not suspected.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 6187938
• MDR Text Key: 62793952
• Report Number: 1823260-2016-02015
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11731459122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2016
• 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