MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 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 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

The calibration and qc data provided were acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The investigation is ongoing.

Event Description

There was an allegation of questionable roche diagnostics cobas elecsys anti-tpo results for 2 patient samples on a cobas 8000 core unit.On (b)(6) 2023, the initial anti-tpo result for sample 1 from an aliquot of the original sample was 35 iu/ml.The original sample was repeated and the result was 11 iu/ml.The sample was repeated again and the result was 9 iu/ml with flag.On (b)(6) 2023, the initial anti-tpo result for sample 2 from an aliquot of the original sample was 66 iu/ml.The original sample was repeated and the result was 9 iu/ml with flag.The sample was repeated again and the result was 9 iu/ml with flag.No questionable results were reported outside of the laboratory.The analyzer serial number is (b)(6).

Manufacturer Narrative

The investigation found that the root cause of the event was consistent with pre-analytical handling issues.

• 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: 16791088
• MDR Text Key: 313829076
• Report Number: 1823260-2023-01371
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• 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
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 07026935190
• Device Lot Number: 66407701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female