IMMULITE
Received Mar 29, 2017 · Event occurred Mar 6, 2017
Report 2247117-2017-00042 · MDR key 6443387
Device
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 2247117-2017-00042 WAS FILED ON MARCH 29, 2017. ADDITIONAL INFORMATION (04/11/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND STATED THAT THERE WAS NO IMPRECISION NOTED ON OTHER SAMPLES, ADJUSTORS OR QUALITY CONTROL MATERIALS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED, BUT SAMPLE INTEGRITY MAY HAVE BEEN AN ISSUE. BASED ON THE AVAILABLE INFORMATION, IMMULITE HCG LOT 440 IS PERFORMING AS INTENDED. THE CAUSE OF THE DISCORDANT, HCG RESULTS ON THIS PATIENT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Additional Manufacturer Narrative
A SIEMENS FIELD APPLICATIONS SPECIALIST (FAS) WAS DISPATCHED TO THE CUSTOMER SITE. THE FAS RAN MULTIPLE REPLICATES OF ADJUSTORS, QUALITY CONTROL MATERIALS AND TWO PATIENT SAMPLES AND DID NOT OBSERVE A PRECISION ISSUE. THE FAS ADVISED THE CUSTOMER ABOUT SAMPLE COLLECTION AND HANDLING PRECAUTIONS. THE CUSTOMER HAS NOT ENCOUNTERED VARIABLE RESULTS ON ANY OTHER PATIENT SAMPLE(S) ON THE IMMULITE HCG ASSAY. THE CUSTOMER IS NOT HAVING ISSUES WITH ANY OTHER RESULTS FROM THIS IMMULITE INSTRUMENT. THE CAUSE OF THE DISCORDANT HCG RESULTS ON THIS PATIENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
THE CUSTOMER OBTAINED DISCORDANT HCG RESULTS ON MULTIPLE DRAWS FROM A PATIENT ON AN IMMULITE INSTRUMENT USING REAGENT LOT 440. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO QUESTIONED IT. REPEAT TESTING WAS PERFORMED ON THE SAME SAMPLE AS WELL AS ON SUBSEQUENT BLOOD DRAWS FROM THIS PATIENT ON THE IMMULITE HCG ASSAY. SOME OF THESE SAMPLES WERE ALSO TESTED FOR HCG ON AN ALTERNATE PLATFORM. IT IS UNKNOWN IF THE REPEAT RESULTS HAVE BEEN PROVIDED TO PHYSICIAN(S). IT IS UNKNOWN IF THE DISCORDANT HCG RESULTS HAVE IMPACTED DIAGNOSIS OR TREATMENT FOR THIS PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE DISCORDANT HCG RESULTS.