MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ANTI-TG AB

Model Number	IMMULITE 2000 ANTI-TG AB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report immulite 2000 xpi anti-tg patient results that are in the normal range compared to an abnormal high patient result obtained with anti-tg on the alternate platform which aligns with the patient's clinical condition.The siemens regional support center (rsc) and headquarter support center (hsc) are investigating this issue.
Event or Problem Description
The customer called siemens to inform that an anti-thyroglobulin (anti-tg) patient result obtained on an alternate platform was abnormal high for anti tg and used to compare against the immulite 2000 xpi anti-tg result.The customer stated that the initial patient test result obtained on the immulite 2000 xpi system is in a normal range and reported to the physician.The initial result was questioned by the physician and the same patient sample was used for repeat testing on an alternate immulite 2000 xpi system.The customer informed that the repeated test result was also in a normal range and not an expected result.The customer stated that the initial result obtained from the alternate platform is correct due to the clinical condition of the patient.There are no reports of patient intervention or adverse health consequence due to the anti-tg discordant patient results.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 21-february-2018.Additional information (03-april-2018): a headquarter support center (hsc) specialist has performed an investigation and determined that without having the sample to test, hsc cannot confirm the customer's results or test on an alternate platform.The most likely cause of the difference in results is due differences in preparation and fixation of the antigen used, buffer and technical modalities implemented and diversity of anti-tg antibodies present in the test sample.Hsc has assisted the regional support center (rsc) specialist with references (e.G., articles) from the national center for biotechnology information to help explain the difference in results between the alternate platform and immulite anti-tg ab assays.The rsc specialist has provided the information to the customer and informs that the customer is satisfied and no further assistance or evaluation is required.

• Brand Name: IMMULITE 2000 ANTI-TG AB
• Common Device Name: IMMULITE 2000 ANTI-TG AB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7287138
• Report Number: 2432235-2018-00085
• Device Sequence Number: 1993934
• Product Code: JZO
• UDI-Device Identifier: 00630414962108
• UDI-Public: 00630414962108
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Model Number: IMMULITE 2000 ANTI-TG AB
• Device Lot Number: 673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR