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

Catalog Number 06368590190

Device Problem High Test Results (2457)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

The customer calibrated and ran controls on the reagent pack, but the calibration and controls failed.The customer removed the reagent pack and placed another pack on board.Calibration and controls were run and were ok.Patient results from the new pack were normal.

Event Description

The initial reporter stated that controls were outside of range for roche diagnostics cobas elecsys anti-tpo on the cobas e 411 immunoassay analyzer (serial number (b)(4)).They also received questionable anti-tpo results for three patient samples.No patient data was provided.The affected samples initially recovered positive anti-tpo values and these values were reported outside of the laboratory.The samples were repeated and resulted in negative anti-tpo values that were over 30 % different from the initial values.The repeated values were also reported outside of the laboratory.

Manufacturer Narrative

Data from the three complained samples were provided as follows: the first patient sample initially resulted in an anti-tpo value of 184.1 iu/ml with a data flag on (b)(6) 2022.The sample was repeated twice on (b)(6) 2022, resulting in values of 15.19 iu/ml and 13.31 iu/ml.The second patient sample initially resulted in an anti-tpo value of 215.8 iu/ml with a data flag on (b)(6) 2022.The sample was repeated twice on (b)(6) 2022, resulting in values of 22.11 iu/ml and 19.14 iu/ml.The third patient sample initially resulted in an anti-tpo value of 486.2 iu/ml with a data flag on (b)(6) 2022.The sample was repeated twice on (b)(6) 2022, resulting in values of 30.22 iu/ml and 24.90 iu/ml.Medwatch field b3.Has been updated.

Manufacturer Narrative

For the last calibration performed on 15-dec-20222, calibration signals were too low.The incorrect calibration signals caused a distorted calibration curve.Quality controls were outside of specifications.Control values were ok again upon the use of another reagent pack.A general reagent issue can be excluded.The investigation determined that the issue was caused by a distorted calibration curve on the reagent pack in question.The investigation could not identify a product problem.The issue is consistent with a reagent pack storage issue.

• Brand Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16121064
• MDR Text Key: 308713912
• Report Number: 1823260-2023-00087
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06368590190
• Device Lot Number: 64648602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• 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