MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) IMMULITE 2000 ANTI -TPO AB

Model Number IMMULITE 2000

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/29/2014

Event Type  malfunction  

Event Description

Imprecise antithyroid peroxidase antibody (anti-tpo ab) results were obtained on one patient sample when run in duplicate on an immulite 2000 xpi instrument using kit lot 611.The sample was repeated twice on the same instrument in replicates of two and three and results were still imprecise.It is unknown if any of the imprecise results were reported to the physician(s).The sample was sent to reference lab and was tested with an alternate methodology and a corrected result was obtained.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the imprecision obtained on anti-tpo ab results.

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the customer's anti-tpo ab data.The hsc observed that the values of the imprecise results were near the assay sensitivity level.The cause of imprecise anti-tpo results is related to true value of the patient sample being near the sensitivity level.

• Brand Name: IMMULITE 2000 ANTI -TPO AB
• Type of Device: IMMULITE 2000 ANTI -TPO AB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944); 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: 4277550
• MDR Text Key: 5034031
• Report Number: 2432235-2014-00694
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Device Catalogue Number: L2KTO
• Device Lot Number: 611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• 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: Reuse
• Patient Sequence Number: 1