MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - 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	12/30/2019
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.Hsc found that antibody assays have poor concordance amongst each other compared to other assays such as thyroid, tumor marker, etc.The poor concordance amongst assays could the most likely cause of the discordance.As there was no sample available that the customer could send to siemens for internal testing, siemens was unable to confirm the customer's observation.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 customer has received and reviewed hsc's response and requires no further support from siemens.The device is performing within specification.No further evaluation of the device is required.Mdr 2432235-2020-00122, mdr 2432235-2020-00123, mdr 2432235-2020-00124, and mdr 2432235-2020-00125 were filed for the same event.
Event or Problem Description
One discordant, falsely depressed anti-thyroglobulin antibody (atg) result was obtained using immulite 2000 xpi on a single patient.Three initial testing using siemens advia centaur xp were considered correct and were reported to the physician(s).Two additional testing using an alternate non-siemens method were also considered correct and were reported to the physician(s).A later test using immulite 2000 xpi was considered discordant but was reported to the physician(s).Another test using siemens atellica im was 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.

• Brand Name: IMMULITE 2000 XPI - ATG
• Common Device Name: IMMULITE 2000 XPI - ATG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9667659
• Report Number: 2432235-2020-00126
• Device Sequence Number: 14306268
• Product Code: JZO
• UDI-Device Identifier: 00630414962108
• UDI-Public: 00630414962108
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 02/04/2020

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: 06/30/2020
• Device Model Number: IMMULITE 2000 XPI - ATG
• Device Catalogue Number: L2KTG2
• Device Lot Number: 735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR