MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED IMMULITE 2000 THYROGLOBULIN

Model Number IMMULITE 2000 THYROGLOBULIN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 06/08/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the failed slopes for the tg assay on the immulite 2000 instrument is unknown.Siemens is investigating the issue.

Event Description

The customer has indicated that they are obtaining failed slopes for the thyroglobulin assay (tg) on the immulite 2000 instrument.A new reagent lot was shipped to the customer site, but the tg slopes continued to fail.Patient samples were not run or reported due to the slope failure on the instrument.The customer has a reported a delay in reporting patient results due to the high slopes on the immulite 2000 instrument.There were no reports of patient intervention or adverse health consequences due to the failed adjustment slopes for the tg assay.

Manufacturer Narrative

The initial mdr 2432235-2016-00387 was filed on july 21, 2016.Additional information (08/08/2016): on (b)(6) 2016, the customer received reagent kit 336, which was kept at the room temperature overnight prior to being refrigerated.The operator performed a slope adjustment on this reagent kit and it failed.The operator repeated the slope adjustment with a fresh adjustor, and the slope failed again.The slope adjustment passed on the third attempt.Quality controls were within acceptable ranges.The customer stated that no patient care was affected due to delay in reporting of patient results.The patient sample results were within expectations.As per immulite 2000 thyroglobulin instructions for use, reagents should be stored at 2-8 degree celsius.The cause of the failed adjustment slopes for the thyroglobulin assay on immulite 2000 instrument is unknown.Corrected information (09/01/2016): (b)(6).

• Brand Name: IMMULITE 2000 THYROGLOBULIN
• Type of Device: IMMULITE 2000 THYROGLOBULIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; glyn rhowny; llanberis, caernarfon; gwynedd, wales, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED; glyn rhowny, llanberis; gwyness, caernarfon; wales, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5811891
• MDR Text Key: 50964565
• Report Number: 2432235-2016-00387
• Device Sequence Number: 1
• Product Code: MSW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 THYROGLOBULIN
• Device Lot Number: 334, 337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• 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