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

Catalog Number 11731459122

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

A physician questioned results for 1 patient sample tested for thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3).The sample was submitted for investigation.Of the data provided, erroneous tsh results were identified between the customer's e602 analyzer, a centaur analyzer and an e 170 analyzer used at the investigation site.All results from the investigation will be reported to the customer.Erroneous results were reported outside of the laboratory.Refer to the attached data for patient results.No adverse event was reported.The e 170 analyzer serial number was (b)(4).The tsh reagent lot number used at the investigation site was 184851 with an expiration date of 11/30/2015.The serial number for the customer's e602 analyzer is not known.A specific root cause could not be identified.Based on the available data, a general reagent issue can most likely be excluded.When comparing values from different types of analyzers, variances can be expected.For thyroid parameters, age, gender and other patient characteristics should be considered when comparing values.

• Brand Name: TSH, THYROTROPIN
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5039388
• MDR Text Key: 25534460
• Report Number: 1823260-2015-04044
• 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: Health Professional
• Report Date: 08/28/2015

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: 11731459122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• 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