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

Catalog Number 09004998190

Device Problems Failure to Calibrate (2440); High Test Results (2457); High Readings (2459); Low Readings (2460); Non Reproducible Results (4029)

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

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas 8000 - cobas e 602 module serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys anti-tg results from the cobas 8000 - cobas e 602 module.The samples were repeated after reagent replacement.Sample 1 initial result was > 4000iu/ml and the repeat result was 285.6 iu/ml.Sample 2 initial result was > 4000iu/ml and the repeat result was 16.12 iu/ml.Sample 3 initial result was > 4000iu/ml and the repeat result was 13.6 iu/ml.The questionable results were not released outside of the laboratory.

Manufacturer Narrative

The investigation could not determine a specific root cause.The event was consistent with a reagent kit handling issue due to transport and/or storage.Quality control was not performed before the patient sample testing.Good laboratory practice precludes running and/or reporting patient results when quality control hasn't been performed.A general reagent problem could be excluded because another reagent kit of the same lot performed according to expectations at this customer site.

• Brand Name: ELECSYS ANTI-TG
• Type of Device: THYROID AUTOANTIBODY TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19197295
• MDR Text Key: 341376053
• Report Number: 1823260-2024-01297
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K053426
• 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
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09004998190
• Device Lot Number: 70642800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1