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

Catalog Number	07026935190
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys anti-tg and elecsys anti-tpo results from six patient samples tested on the cobas e 801 analytical unit with serial number (b)(4).This medwatch is for the anti-tpo assay.Please refer to medwatch with patient identifier (b)(6) for the anti-tg assay.The initial results were not reported outside of the laboratory.The results were compared to three other non-roche analyzers.The reporter complained that the results from the three non-roche analyzers were all in accordance and only the results from the reported analyzer were low.Please refer to the attachment in the medwatch for the highlighted questionable results.
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
The customer uses the same reference range as the other laboratory.The qcs were within specifications.As per the summary of the analysis of the calibration signals and control values, a general reagent issue most likely can be excluded.For sample (b)(6) both the values generated with the cobas e 801 module and the centaur analyzer are clearly above the cutoff value of the anti-tg assays.Hence, the same clinical interpretation applies.For all samples (b)(6) the following applies: in case auto-antibodies (such as anti-tg but also anti-tpo) are measured, the results can vary depending on the testing procedure used.Biological samples can generate different anti-tg values from different assays from different suppliers.Product labeling states "the measured anti-tg value of a patient's sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the anti-tg assay method used.Anti-tg values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.If there is a change in the anti-tg assay procedure used while monitoring therapy, then the anti-tg values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods." from the information provided and the analysis thereof, a general reagent issue most likely can be excluded.

• Brand Name: ELECSYS ANTI-TPO
• 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: 16149916
• Report Number: 1823260-2023-00118
• Device Sequence Number: 12179298
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K051890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 04/21/2023

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: 07026935190
• Device Lot Number: ASKU
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 04/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SAMPLE ID (B)(6) - UNSPECIFIED THYROID MEDICATION.; SAMPLE ID (B)(6) - UNSPECIFIED THYROID MEDICATION.; SAMPLE ID (B)(6) - UNSPECIFIED THYROID MEDICATION.
• Patient Sex: Unknown