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

Catalog Number 07026935190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The e801 module serial number is (b)(6).

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys anti-tpo (anti-tpo) on a cobas 8000 e 801 module.The initial result was 73.2 iu/ml.The sample was repeated twice with results of less than 9 iu/ml.The repeat results were believed to be correct as these matched the patient¿s previous anti-tpo results.

Manufacturer Narrative

The field service engineer (fse) performed repeatability testing for anti-tpo and confirmed there were no issues.

Manufacturer Narrative

Calibration and qc were acceptable.No issues were identified during a review of the alarm trace data.Due to the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19041294
• MDR Text Key: 339986103
• Report Number: 1823260-2024-01035
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (y/n): Y
• 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: 04/22/2024

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 Catalogue Number: 07026935190
• Device Lot Number: 750634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/10/2024; 04/19/2024
• Supplement Dates FDA Received: 04/12/2024; 04/22/2024
• 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