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

Model Number E411 DISK

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with roche diagnostics cobas elecsys anti-tpo ver.3 on a cobas e 411 immunoassay analyzer.No incorrect results were reported outside of the laboratory.The sample was initially tested on the e411 analyzer, resulting in an anti-tpo value of 79 iu/ml (expected value = < 34 iu/ml).The result did not match the clinical picture of the patient, so the sample was sent to another laboratory for testing on a cobas 6000 e 601 module.The result from the e 601 analyzer was < 5.0 iu/ml (expected value = < 34 iu/ml) on (b)(6) 2022.The sample was repeated again on the e411 analyzer, resulting in a value of around 84 iu/ml.The anti-tpo reagent lot number was 54394103, with an expiration date of 31-mar-2022.

Manufacturer Narrative

The last calibration and control measurements were performed on 07-jan-2022 and the complained results were generated on 11-jan-2022.Per product labeling, calibration is required daily when using the same reagent kit on the analyzers.Qc measurements performed prior to the measurement performed on 07-jan-2022 showed highly elevated results.No sample from the patient was available for investigation.The investigation could 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
• 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: 13416578
• MDR Text Key: 291733758
• Report Number: 1823260-2022-00258
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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
• Report Date: 02/08/2022

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: 03/31/2022
• Device Model Number: E411 DISK
• Device Catalogue Number: 06368590190
• Device Lot Number: 54394103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/08/2022
• 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