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

Catalog Number 11731459122

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable elecsys tsh assay results for two patients from cobas 8000 - cobas e 602 module serial number (b)(4).Patient 1: the initial tsh result was 0.04 mu/l.When tested by an abbott method, the result was 0.22 mu/l and when tested by a siemens method, the result was 0.21 mu/l.The customer repeated the sample on the cobas e 602 module and the tsh results were 0.049 and 0.046 mu/l.The patient then started treatment with tramazol.On (b)(6) 2018, the tsh result from the cobas e 602 module was 0.11 mu/l and when tested by an abbott method, the result was 0.37 mu/l.Patient 2: ((b)(6)) on (b)(6) 2018, the tsh result was 57.13 mu/l.When tested by an abbott method, the tsh result was 19.6 mu/l.The patient did not receive any treatment.The customer suspected macro tsh.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event for either patient.Samples from both patients were submitted for investigation.For patient 2, the customer's high result was confirmed and an interfering factor could be excluded.

Manufacturer Narrative

Samples from both patients were submitted for investigation.Patient 1: an interfering factor was found to be present in the sample.This interference is documented in product labeling for the assay.Patient 2: upon further investigation, macro tsh was found to be present in the sample.This interference is documented in product labeling for the assay.

• 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: 7650434
• MDR Text Key: 113019979
• Report Number: 1823260-2018-02136
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 29489700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• 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: 85 YR