MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 ANTI-TG AB

Model Number IMMULITE 2000 ANTI-TG AB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide the patient sample for in-house testing.A siemens headquarters support center (hsc) specialist reviewed the information provided by the customer.As per immulite 2000 xpi instructions for use, "as with any immunoassay test on the immulite 2000 system results obtained from the assay should always be used in combination with the clinical examination, patient medical history, and other findings".The hsc specialist stated that the differences in results could be due to different assay standardizations, the use of different antibodies between the two assays, or the difference in assay architectures.The cause of the discordant, falsely low anti-tg ab results on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Discordant, falsely low autoantibodies to thyroglobulin (anti-tg ab) results were obtained on one patient sample upon initial and repeat testing on an immulite 2000 xpi instrument.The reagent lot was not provided by the customer.The sample was sent to an alternate laboratory where it was tested on an alternate platform, resulting higher.The initial result was reported to the physician(s) and questioned.It is unknown if the result obtained on the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low anti-tg ab results.

• Brand Name: IMMULITE 2000 ANTI-TG AB
• Type of Device: IMMULITE 2000 ANTI-TG AB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; glyn rhonwy; llanberis, caernarfon; gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944); glyn rhonwy; llanberis, caernarfon; gwynedd, wales LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6558527
• MDR Text Key: 74906353
• Report Number: 2432235-2017-00306
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 ANTI-TG AB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1