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 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys anti-tpo results for 3 patients on a cobas e 801 analytical unit, serial number (b)(4).Patient 1: the initial result was 80.1 iu/ml (primary tube).On (b)(6) 2022, the repeated result was 15.0 iu/ml (from the same primary tube).Patient 2: on (b)(6) 2022, the initial result was 70.1 iu/ml (primary tube).On (b)(6) 2022, the repeated result was 9 iu/ml (from the same primary tube).Patient 3: on (b)(6) 2022, the initial result was 66 iu/ml.On (b)(6) 2022, the repeated result was <34 iu/ml.The repeated results were performed on another e801 module.The results were reported outside of the laboratory.The repeated results were believed to be correct.

Manufacturer Narrative

Additional results for patient 1 were provided: on (b)(6) 2022 the gamgt result was 31.On (b)(6) 2022 the cpk result was 69.On (b)(6) 2022 the fshte result was 0.3.On (b)(6) 2022 the lhte result was 0.3.On (b)(6) 2022 the aatir result was 15.On (b)(6) 2022 the aatpote result was 34.On (b)(6) 2022 the prlte result was 7.The units of measure for the additional results were not provided.The daily alarm trace contained 3 sample clot alarms.The customer performed a liquid flow clean maintenance before (b)(6) 2022) and after (b)(6)2022) the event.

Manufacturer Narrative

The customer's calibration was acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14205678
• MDR Text Key: 290059189
• Report Number: 1823260-2022-01176
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 06/24/2022

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 Catalogue Number: 07026935190
• Device Lot Number: 590342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 04/25/2022; 06/01/2022
• Supplement Dates FDA Received: 05/18/2022; 06/24/2022
• 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
• Patient Age: 38 YR
• Patient Sex: Male