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 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's calibration and qc data was acceptable.The sample was requested for investigation, however, the sample is no longer available.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys estradiol iii (estradiol iii), elecsys anti-tpo (anti-tpo) and elecsys t3 (t3) on either a cobas 8000 e 602 module or a cobas e801 module compared to an unspecified chemiluminescence method.This medwatch will cover anti-tpo.Refer to medwatch with a1 patient identifier (b)(6) for information on the estradiol iii results and medwatch with a1 patient identifier (b)(6) for information on the t3 results.Refer to attached data for the patient results.The initial results were reported outside of the laboratory.The repeat results from the chemiluminescence method were believed to be correct.The e602 module serial number was (b)(4).The e801 module serial number was (b)(4).

Manufacturer Narrative

Calibration and qc for all assays were acceptable.The customer's results for all roche assays were above the applicable reference ranges.The results for the same tests from an unspecified chemiluminescence method were within the applicable reference ranges.Sample material was requested for investigation but could not be provided.Neither a general instrument or reagent issue were identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 9948187
• MDR Text Key: 214824503
• Report Number: 1823260-2020-01010
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K051890
• 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: 05/22/2020

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: 07/31/2020
• Device Catalogue Number: 06368590190
• Device Lot Number: 424366, 439067
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR