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

Catalog Number	06368697190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-02048
• Device Sequence Number: 1737390
• Product Code: JZO
• UDI-Device Identifier: 04015630929726
• UDI-Public: 04015630929726
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K053426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 06368697190
• Device Lot Number: 59536801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female