MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 - ATG

Model Number	IMMULITE 2000 XPI - ATG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center the headquarters support center (hsc) reviewed the information provided by the customer.The hsc found that anti-tg assays use different antibodies, have different assay architecture, different cutoff values, and have different assay standardization depending on the instrument used.The difference may lead to non-agreeable results on a patient sample.The hsc found that antibody assays have poor concordance when compared to other assays such as thyroid and tumor marker.The hsc provided the following publications to the customer on the topic of assay concordance: https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc3123526/.Https://www.Ncbi.Nlm.Nih.Gov/pubmed/21325460.Https://www.Ncbi.Nlm.Nih.Gov/pubmed/21502198.Https://www.Ncbi.Nlm.Nih.Gov/pubmed/? term=causes+of+discordance+between+thyroglobulin+antibody+assays.The cause for the discordant falsely depressed atg samples results is unknown.The device is performing within specification.No further evaluation of the device is required.
Event or Problem Description
Four discordant, falsely depressed anti-thyroglobulin antibody (atg) results on a single patient were obtained using immulite 2000 xpi on the same day.The initial result was reported and questioned by the physician(s).Three repeat results using the same immulite 2000 xpi were considered discordant.Three repeat results using an alternate non-siemens method were considered correct and reported to the physician(s).Two additional repeat results using siemens atellica solutions were also considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated atg results.
Additional Manufacturer Narrative
Initial mdr 2432235-2019-00231 was filed on (b)(6)2019.Additional information ((b)(6)2019): the headquarters support center (hsc) reviewed the information provided by the customer and requested internal testing on the patient sample.The internal testing results were negative on immulite 2000 and positive on the atellica solution to confirm the customer's observation.The most likely cause of the discordance in results is that the customer is using the assay as a surrogate tumor marker rendering the reportable limit lower than other methods.Thyroid cancer patients fall in the undetectable assay range.The assay was not designed to be a tumor marker assay.Additionally, the information for use (ifu) describe the intended use of atg is for in vitro diagnostic use with the immulite® 2000 systems analyzers for the quantitative measurement of autoantibodies to thyroglobulin (tg) in serum, edta, and heparinized plasma, as an aid in the clinical diagnosis of thyroid diseases.The customer requires no further support from siemens for this issue.Section updated to reflect the additional information.The device is performing within specification.No further evaluation of the device is required.
Additional Manufacturer Narrative
Initial mdr 2432235-2019-00231 was filed on 5-jul-2019.Mdr 2432235-2019-00231-s1 was filed on 2-oct-2019 additional information (19-sep-2019): the headquarters support center (hsc) reviewed the information provided by the customer and requested internal testing on the patient sample.The internal testing results were negative on immulite 2000 and positive on the atellica solution to confirm the customer's observation.The most likely cause of the discordance in results is that the customer is using the assay as a surrogate tumor marker.The assay was not designed to be a tumor marker assay.The customer requires no further support from siemens for this issue.Sections h10 was updated to reflect the additional information.

• Brand Name: IMMULITE 2000 - ATG
• Common Device Name: IMMULITE 2000 - ATG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 8765362
• Report Number: 2432235-2019-00231
• Device Sequence Number: 14027430
• Product Code: JZO
• UDI-Device Identifier: 00630414962108
• UDI-Public: 00630414962108
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K991094
• 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,Followup
• Report Date (Section B): 10/03/2019

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 Expiration Date: 11/30/2019
• Device Model Number: IMMULITE 2000 XPI - ATG
• Device Catalogue Number: L2KTG2
• Device Lot Number: 698
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 09/19/2019; 09/19/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 10/02/2019; 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR