MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number 06368590190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of questionable roche diagnostics cobas elecsys anti-tpo (a-tpo) results for one patient sample run on a cobas 6000 e 601 module (e601).On (b)(6) 2017 the initial a-tpo result was >600 iu/ml, with a data flag.The sample was repeated undiluted with a result of >600 iu/ml, with a data flag.A manual 1:5 dilution was performed per the method sheet recommendation and calculated results of 231.4 iu/ml, 215.1 iu/ml, and 228.8 iu/ml were obtained.The customer also performed a non-validated 1:2 manual dilution and obtained a result of 498 iu/ml despite being aware of the non-linear dilution phenomenon that is noted in the a-tpo method sheet.On (b)(6) 2017 a second tube from the same draw was run.The initial a-tpo result was >600 iu/ml with a repeated result of >600 iu/ml.A manual 1:5 dilution was performed and a calculated result of 224.45 iu/ml was obtained.The customer sent the patient sample to a reference laboratory.The reference laboratory ran a thyroperoxidase antibody assay on a beckman dxi 800 a received a result of 17.7 iu/ml.No results have been released outside of the laboratory as customer does not know what results to believe.There have been no adverse events.The samples were both processed by a modular pre-analytics system and manually loaded onto the analyzer.The e601 serial number was (b)(4).The field engineering specialist was unable to determine a cause.He performed performance and instrument checks all which passed.The customer performed qc testing which passed.

Manufacturer Narrative

The investigation stated the mathematical difference between the undiluted and diluted measurements relates to how the autoantibodies are heterogeneous and thus gives rise to non-linear dilution phenomena for individual samples.This is noted in cobas elecsys anti-tpo method sheet.The difference in results between the cobas 6000 e 601 module and the beckman platform can be related to the overall difference in the setups of the assays, the antibodies used, and the difference in reference materials used in the standardization methodology.The beckman result that was generated was also above the cutoff of the assay.Evaluation summary updated.

Manufacturer Narrative

Evaluation result code and evaluation conclusion code updated.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 6897107
• MDR Text Key: 89415807
• Report Number: 1823260-2017-02117
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2017

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: 01/31/2018
• Device Catalogue Number: 06368590190
• Device Lot Number: 17904401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/08/2017; 09/08/2017
• Supplement Dates FDA Received: 10/10/2017; 10/31/2017
• 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: 71 YR