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

Catalog Number 07026935190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer performed multiple actions on the involved analyzers, including parts replacements, cleaning procedures, adjustments, and performance testing.The issue still occurs and troubleshooting is ongoing.This event occurred in (b)(6).Udi number = (b)(4).

Event Description

The initial reporter stated they received discrepant results for three patient sample tested with roche diagnostics cobas elecsys anti-tpo on multiple cobas 8000 e 801 module analyzers.No incorrect results were reported outside of the laboratory for the first sample.It is unknown if any incorrect results were reported outside of the laboratory for the second and third samples.At the time the event started, the customer was using anti-tpo reagent lot number 52267901, with an expiration date of 31-jul-2021.The first sample initially resulted in an anti-tpo value of 48 iu/ml and repeated as 15 iu/ml on e 801 analyzer serial number (b)(4).On (b)(6) 2021, the second sample initially resulted in an anti-tpo value of 55 iu/ml and repeated with values of 12 iu/ml and 12 iu/ml.The e 801 analyzer serial number used for testing of this sample was either serial number (b)(4) or serial number (b)(4).The specific analyzer serial number used for testing is not known.As of (b)(6) 2021, the customer started using anti-tpo reagent lot number 538863.The expiration date for this lot number was requested, but not provided.On (b)(6) 2021, the third sample initially resulted in an anti-tpo value of 37 iu/ml when tested on e 801 serial number (b)(4).The sample was repeated twice using e 801 analyzer serial number (b)(4) on (b)(6) 2021, resulting in values of 10 iu/ml and 11 iu/ml.

Manufacturer Narrative

Upon analysis of data files from the affected analyzers, it was determined that overall performance of the analyzers and assays were very good.Data analysis revealed the issue to be consistent with poor sample quality.It was also determined that the sample containers used by the customer have an outer diameter of 12.5 mm.The tube walls are also relatively thick and they have a conical bottom.Per product labeling, the minimum required tube diameter for the e 801 analyzer is 13 mm.

Manufacturer Narrative

Investigations have determined the issue is consistent with incorrect pre-analytic handling.

• 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: 12076065
• MDR Text Key: 258718743
• Report Number: 1823260-2021-01846
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2022

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: 07/31/2021
• Device Catalogue Number: 07026935190
• Device Lot Number: 52267901, 538863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 12/17/2021; 02/03/2022
• Supplement Dates FDA Received: 12/22/2021; 02/28/2022
• 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
• Patient Sequence Number: 1