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

Catalog Number 08429324160

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable tsh results on a cobas 6000 e601 module serial number, (b)(4).The initial result was 0.028 iu/ml and the repeated result was 2.33 iu/ml.The initial result was reported outside of the laboratory.The repeated result was believed to be correct.

Manufacturer Narrative

The field service engineer found damaged measuring cells that he replaced.The customer calibrated and ran controls.Calibration and qc data provided by the customer were acceptable.The alarm trace from the analyzer contained an abnormal aspiration alarm, indicating possible poor sample quality.The investigation determined that the issue found by the fse was the root cause of the event.

• 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: 10742457
• MDR Text Key: 214803346
• Report Number: 1823260-2020-02676
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 08429324160
• Device Lot Number: 466153
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR