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 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4ii), and elecsys ft4 iii assay (ft4iii) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.Patient identifiers for information related to each affected assay: (b)(6).Refer to the attachment for all patient data.The sample was initially tested for tsh and ft4ii on the e602 analyzer at the customer site on (b)(6) 2018.The sample was provided for investigation, where it was tested for tsh, ft4ii, and ft3 on a second e602 analyzer on (b)(6) 2018.During the investigation, the sample was also tested for ft4iii on the second e602 analyzer on (b)(6) 2018.The sample was also repeated on a centaur analyzer on (b)(6) 2018.No adverse events were alleged to have occurred with the patient.The serial number of the e602 analyzer used at the customer site was (b)(4).The serial number of the e602 analyzer used for the investigation was (b)(4).Tsh reagent lot number 291617, with an expiration date of july 2018 was used on this analyzer.No abnormalities were observed with calibration and control data from the e602 analyzer used for investigation.Based on the provided data, a general reagent issue can most likely be excluded.The investigation was unable to find a definitive root cause.

• 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: 7596438
• MDR Text Key: 111473598
• Report Number: 1823260-2018-01888
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• 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: 23 YR