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

Model Number IMMULITE 2000 ANTI-TG AB

Device Problems False Reading From Device Non-Compliance (1228); High Test Results (2457)

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

Event Date 07/18/2014

Event Type  malfunction  

Event Description

The customer obtained discordant, falsely elevated results on one patient sample for anti thyroglobulin antibody (atg) assay on an immulite 2000 instrument.The reagent lot was not provided by the customer.A new sample was obtained from the patient and was tested on same instrument and the result was still elevated.The sample was also tested on an alternate platform in a reference lab and the result was lower.Another new sample was obtained from the patient and was tested on an immulite 2000 xpi instrument and the result was elevated again.The patient sample was then tested on an alternate immulite 2000 instrument in a reference lab and the results were still high.It is unknown from the complaint if this was a new draw from the patient or an older sample.The samples were also tested on three alternate platforms in a reference lab and the results were lower.The falsely elevated results were reported to the physician(s) and questioned.The lower results from the alternate platform was also reported to the physician(s) there are no known reports of patient intervention or adverse health consequences due to the falsely elevated atg results on the patient sample.

Manufacturer Narrative

The cause of discordant, falsely elevated anti thyroglobulin antibody results is unknown.Siemens healthcare diagnostics is investigating the issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00650 was filed on november 14, 2014.The first supplemental mdr was filed on december 12, 2014.Additional information (01/14/2014): a siemens regional support center (rsc) specialist requested the patient sample for additional testing, but it is not available.The samples were not viable for use as the customer stored the sample at (-)80 degrees celsius, which is not recommended as per anti thyroglobulin antibody (atg) instructions for use.The cause of falsely elevated atg results on one patient sample is unknown.

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained discordant, falsely elevated results on one patient sample for anti thyroglobulin antibody (atg) assay on an immulite 2000 xpi instrument using kit lot 598.The sample was tested on an alternate platform in a reference lab and the result was lower.A new sample was obtained from the patient and was tested on same instrument and the result was still elevated.The patient sample was then tested on an alternate immulite 2000 instrument in a reference lab and the results were still high.It is unknown if this was a new draw from the patient or an older sample.The samples were also tested on three alternate platforms in a reference lab and the results were lower.The falsely elevated results were reported to the physician(s) and questioned.The lower results from the alternate platform were also reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated atg results on the patient sample.

• 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: elizabeth beato ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243074
• MDR Report Key: 4252251
• MDR Text Key: 5044362
• Report Number: 2432235-2014-00650
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K991094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• 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 Catalogue Number: L2KTG
• Device Lot Number: 598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• 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
• Patient Age: 39 YR