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

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay on two cobas 8000 e 801 module analyzers.The sample also had a discrepant result for the elecsys tsh assay ver.2 when tested on the second e 801 analyzer.This medwatch will apply to the elecsys tsh assay ver.2.Patient identifier (b)(6) for information related to the elecsys tsh assay.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on an abbott architect.The value from the architect analyzer was believed to be correct.The sample was also provided for investigation, where it was tested on a second e 801 analyzer.The e 801 analyzer used at the customer site is serial number (b)(4).The e 801 analyzer used for investigation is serial number (b)(4).Elecsys tsh assay ver.2 reagent lot number 440704, with an expiration date of march 2021 was used on this analyzer.

• 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: 10459931
• MDR Text Key: 206161292
• Report Number: 1823260-2020-02116
• 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: 08/27/2020

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 Expiration Date: 03/31/2021
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 440704
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• 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