IMMULITE 2000/IMMULITE 2000 XPI GASTRIN
Received Nov 17, 2017 · Event occurred Oct 26, 2017
Report 2432235-2017-00616 · MDR key 7041464
Device
Generic name
Immulite 2000/immulite 2000 Xpi Gastrin
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedModel number
IMMULITE 2000/IMMULITE 2000 XPI GASTRINCatalog number
L2KGA2
Lot number
252
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2017-00616 WAS FILED ON 17-NOV-2017. ADDITIONAL INFORMATION (06-DEC-2017): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT BIOTIN INTERFERES WITH THE GASTRIN ASSAY ON THE IMMULITE 2000/ IMMULITE 2000 XPI PLATFORM. AT BIOTIN CONCENTRATIONS OF >2 NG/ML A NEGATIVE BIAS THAT EXCEEDS 10% HAS BEEN OBSERVED ON IMMULITE 2000/ IMMULITE 2000 XPI PLATFORMS. THIS ISSUE AFFECTS PREVIOUSLY MANUFACTURED, IN-DATE, AND FUTURE LOTS. THE IMMULITE 2000/ IMMULITE 2000 XPI PLATFORM INSTRUCTIONS FOR USE (IFU'S) CURRENTLY DO NOT HAVE BIOTIN LISTED AS A POTENTIAL INTERFERENT. AN URGENT FIELD SAFETY NOTICE (UFSN) IMC 18-02.A.OUS WAS SENT OUT TO OUS CUSTOMERS AND AN URGENT MEDICAL DEVICE RECALL (UMDR) IMC18-02.A.US WAS SENT TO US CUSTOMERS ON DECEMBER 13, 2017. THE UFSN AND UMDR INFORMS THE CUSTOMERS OF BIOTIN INTERFERENCE ON ALL AFFECTED IMMULITE ASSAYS. SIEMENS WILL UPDATE ALL IFU'S WITH THE APPROPRIATE BIOTIN INFORMATION.
Additional Manufacturer Narrative
CORRECTED INFORMATION (12/18/2017): BASED ON INPUT FROM THE (B)(4) RECALL COORDINATOR ON 12/18/2017 THIS RECALL WAS RE-SUBMITTED TO THE (B)(4) OFFICE (ORADEVICES1RECALLS@FDA.HHS.GOV). THE CRR REPORTING NUMBER INDICATED IS INCORRECT AND WAS CHANGED TO 2432235-12/19/2017-004-C. IN ADDITION IT WAS INDICATED THAT AN "URGENT MEDICAL DEVICE RECALL (UMDR) WAS SENT TO US CUSTOMERS. THIS IS INCORRECT AS AN "URGENT MEDICAL DEVICE CORRECTION (UMDC)" WAS SENT TO US CUSTOMERS ON DECEMBER 13, 2017.
Additional Manufacturer Narrative
SIEMENS IS EVALUATING THE ISSUE.
Description of Event or Problem
SIEMENS TECHNICAL OPERATIONS INTERNAL INVESTIGATION HAS IDENTIFIED THAT DISCORDANT FALSELY LOW RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE 2000/ IMMULITE 2000 XPI INSTRUMENT WHEN USING THE GASTRIN ASSAY. THE TWO INVESTIGATIONAL SAMPLES WERE SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE 2000/IMMULITE 2000 XPI INSTRUMENT. THE RESULTS OF THE TWO SAMPLES SPIKED WITH 19 NG/ML OF BIOTIN WERE FALSELY LOW WITH A BIAS OF -52% AND -51% RESPECTIVELY COMPARED TO RESULTS OF THE TWO SAMPLES WITHOUT BIOTIN. THERE WERE NO PATIENT SAMPLES IMPACTED AS THIS WAS FOR INVESTIGATIONAL PURPOSES ONLY.
Remedial action
- Recall