inforMED
MalfunctionMSW

IMMULITE 2000 THYROGLOBULIN

Received Jul 21, 2016 · Event occurred Jun 8, 2015

Report 2432235-2016-00387 · MDR key 5811891

Device

Generic name

Immulite 2000 Thyroglobulin

Lot number

334, 337

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Insufficient Device Problem Information
  • Adverse Event Without Identified Device or Use Problem
  • Insufficient Device Problem Information

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional 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).

Additional Manufacturer Narrative

THE CAUSE OF THE FAILED SLOPES FOR THE TG ASSAY ON THE IMMULITE 2000 INSTRUMENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

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.