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

Catalog Number 06368697190

Device Problem High Test Results (2457)

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

Event Date 06/12/2022

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant high results for 1 patient sample tested for elecsys anti-tg (anti-tg) on two cobas 6000 e 601 modules compared to an unspecified method from another hospital.On (b)(6) 2022 the result from the e601 module was 510.600 iu/ml.This result was reported outside of the laboratory.On (b)(6) 2022 the patient went to another hospital to check the result.The result at the other hospital was 60.02 iu/ml.On (b)(6) 2022 the customer sent the original sample to another hospital and the result was 58.50 iu/ml.On (b)(6) 2022 the sample was repeated on the e601 module in question and the result was 583.6 iu/ml.The customer ran the sample on another e601 module and the result was 552.1 iu/ml.The serial number for one e601 module was 26e4-23.The serial number for the other e601 module was not provided.

Manufacturer Narrative

Clarification was received that the anti-tg results originally reported of 60.02 iu/ml and 58.50 iu/ml were from a different sample from a different patient.The anti-tg results of 510.600 iu/ml, 583.6 iu/ml and 552.1 iu/ml were the results from the sample in question for the patient in this case.These results are not discrepant.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-TG
• 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: 14984798
• MDR Text Key: 304612775
• Report Number: 1823260-2022-02048
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630929726
• UDI-Public: 04015630929726
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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,Followup
• Report Date: 08/09/2022

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: 06368697190
• Device Lot Number: 59536801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/09/2022
• 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 Sex: Female