MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Quality control was acceptable on date of patient testing.The investigation is ongoing.

Event Description

The initial reporter questioned high elecsys tsh assay and elecsys ft4 iii assay results on a cobas 6000 e 601 module.The customer provided questioned results for one patient.The patient¿s initial tsh result was 6.70 uiu/ml and ft4 result was 39.8 pmol/l.The initial results were reported outside the laboratory.The physician questioned the results due to the results not fitting the patient¿s clinical picture.The customer performed repeat testing with another analyzer, abbott, and recovered a tsh result of 4.41 mu/i and ft4 result of 20.6 pmol/l.The repeat results were determined to be correct and reported outside the laboratory.Cobas 6000 e 601 module serial number used for patient testing was (b)(4).This medwatch is for tsh.Refer to the medwatch with patient identifier (b)(4) for the ft4 assay.

Manufacturer Narrative

Based on the investigation, the customer's tsh result could be confirmed.A general reagent issue could be excluded and no interfering factor was identified against the tsh assay.The differences in tsh results between the roche and abbot methods relate to differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9749816
• MDR Text Key: 220297725
• Report Number: 1823260-2020-00545
• 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
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: TSH
• Device Catalogue Number: 08429324190
• Device Lot Number: 42740101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMIODARON; CALCIMAGON D3 FORTE; ELIQUIS; ELTROXIN; MAGNESIUM; VALSARTAN