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

Catalog Number	06368590190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with roche diagnostics elecsys anti-tg and roche diagnostics cobas elecsys anti-tpo on a cobas 6000 e 601 module.The results were reported outside of the laboratory to a clinician who questioned the values.This medwatch will apply to the anti-tpo assay.Please refer to the medwatch patient identifier (b)(6) for information related to the anti-tg assay.The sample was tested twice on the e 601 analyzer, resulting in anti-tg values of 27.13 iu/ml and 27.09 iu/ml (reference range = < 115 iu/ml).The sample was repeated on an alinity analyzer on (b)(6) 2021, resulting in an anti-tg value of 195.05 iu/ml (reference range = < 4.11 iu/ml).The sample was tested twice on the e 601 analyzer, resulting in anti-tpo values of 28.00 iu/ml and 27.28 iu/ml (reference range = < 34 iu/ml).The sample was repeated on an alinity analyzer on (b)(6) 2021, resulting in an anti-tpo value of 27.90 iu/ml (reference range = < 5.6 iu/ml).The serial number of the e 601 analyzer is 2717-16.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.There was no sample remaining for investigation.Discrepant values can be generated due to methodological differences.However, an interfering factor against a component of the assay cannot be excluded.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12355474
• Report Number: 1823260-2021-02441
• Device Sequence Number: 11845567
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K051890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 06368590190
• Device Lot Number: 543941
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR