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

Model Number E411 DISK

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.(b)(4).

Event Description

The initial reporter questioned high roche diagnostics cobas elecsys anti-tpo results on a cobas e411 disk.The customer provided questionable results for 14 patients.Refer to the attachment on the medwatch for all patient data.On (b)(6) 2020, the customer had acceptable anti-tpo calibration and quality control results before processing patients.That afternoon, the customer detected high patient results and decided to run quality control material to verify test performance.The quality control recovered high for both levels.The high patient results were not reported outside the laboratory.On (b)(6) 2020, the customer replaced the anti-tpo reagent pack and had acceptable calibration and quality control results.The customer performed repeat testing on the patient samples that previously had high anti-tpo results.Anti-tpo reagent lot used for patient testing was 439067 with an expiration date of 30-sep-2020.

Manufacturer Narrative

Update to field d1, d2, d4, g1 and g5.The investigation did not identify a general analyzer issue or 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: 9830691
• MDR Text Key: 220822120
• Report Number: 1823260-2020-00730
• 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: 04/03/2020

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: 09/30/2020
• Device Model Number: E411 DISK
• Device Catalogue Number: 06368590190
• Device Lot Number: 439067
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1