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 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer performed a tsh dilution test with the following results: original: 15.100 uiu/ml, diluted: 14.200 uiu/ml, diluted: 14.200 uiu/ml, x10 diluted:14.200 uiu/ml.

Event Description

The customer questioned thyroid results for 1 patient sample tested for elecsys tsh (tsh), elecsys ft4 iii (ft4 iii), and elecsys ft3 iii (ft3 iii) on a cobas e 801 module compared to the accuraseed method.The patient sample was submitted for investigation where discrepant results were identified for tsh and ft4 iii between the customer's e801 module, the architect method and an e801 module used at the investigation site.The initial results from the customer site were reported outside of the laboratory.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(4) for information on the ft4 iii results.Refer to the attached data for the patient results.The customer's e801 module serial number was (b)(4) the e801 module serial number used at the investigation site was (b)(4).The tsh reagent lot number used at the investigation site was 416233 with an expiration date of oct-2020.

Manufacturer Narrative

Section b3, date of event was corrected.

Manufacturer Narrative

All tsh values, from all analyzers involved, were considerably above the normal reference range for each respective assay.Calibration and qc at the investigation site were acceptable.From the information available, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9775363
• MDR Text Key: 220323956
• Report Number: 1823260-2020-00605
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

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 Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 02/06/2020
• Supplement Dates FDA Received: 03/04/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR