MAUDE MDR 5544760

MDR report key
5544760
Report number
1217157-2016-00039
Event key
0
Event type
3
Date of event
2016-03-09
Date received
2016-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEVEN ANDBERG
Address
2 EDGEWATER DRIVE NORWOOD MA 02062 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RAPIDPOINT 405RP 405SIEMENS HEALTHCARE DIAGNOSTICSGKR10322347Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-040

Event Narratives#

N

Patient 1

SIEMENS GLOBAL PRODUCT SUPPORT RECEIVED THE TRACE LOG AND SENSOR DATA FROM CUSTOMER. AFTER REVIEW OF DATA THE INSTRUMENT WAS PROVED NOT AT FAULT. THE ISSUE IS DETERMINED TO BE COMPLETELY AN OPERATOR ERROR. REVIEW SHOWED THAT THE CUSTOMER WAS USING THE LAST PATIENT OPTION IS ENABLED. (THIS IS TURNED ON BY SELECTING SAVE DEMOGRAPHICS ON THE ANALYSIS OPTIONS SCREEN IN SETUP UNDER SECURED OPTIONS). THIS IS AN INCORRECT USE OF THIS FEATURE WHICH IS ONLY MEANT FOR REPEATED SAMPLES FROM THE SAME PATIENT IN AN OR TYPE ENVIRONMENT. UNLESS THIS INSTRUMENT IS IN AN OPERATING ROOM OR OTHERWISE DEDICATED TO RUNNING MULTIPLE SAMPLES FOR THE SAME PATIENT BACK-TO-BACK-TO-BACK THE OPTION IN SETUP -> SECURED OPTIONS -> ANALYSIS OPTIONS FOR "SAVE DEMOGRAPHICS" (WHICH ADDS THE "LAST PATIENT" BUTTON TO THE PATIENT DATA ENTRY SCREEN) SHOULD BE DE-SELECTED. THE "LAST PATIENT" BUTTON WAS INTENDED TO SUPPORT A VERY SPECIFIC NICHE NEED (OPERATING ROOMS WHERE THE OPERATOR WILL NEED TO RUN MANY SAMPLES FOR THE SAME PATIENT OVER AND OVER AND WANTED A WAY TO QUICKLY POPULATE PATIENT DEMOGRAPHICS WITH A SINGLE BUTTON CLICK SO THAT THEY COULD GET BACK TO TENDING TO THEIR PATIENT). ALL OTHER SITUATIONS SHOULD HAVE THIS OPTION TURNED OFF. CUSTOMER WAS EXPLAINED THAT SAVE DEMOGRAPHICS SHOULD BE DESELECTED (TURNED OFF WITH NO CHECKMARK SO THE SAME PATIENT INFORMATION WILL NOT STAY IN ANALYZER FOR THE NEXT SAMPLE). ONLY IN DEPARTMENTS WHERE THE OPERATOR NEEDS TO RUN MANY SAMPLES ON THE SAME PATIENT OVER AND OVER AGAIN (E.G. OPERATING ROOM) WOULD IT BE SELECTED. CUSTOMER UNDERSTOOD GIVEN EXPLANATION AND DOES NOT NEED ANY FURTHER ASSISTANCE FROM SIEMENS. SYSTEM IS PERFORMING AS INTENDED.

D

Patient 1

CUSTOMER REPORTED THAT THEY SCANNED A PATIENT RESULT AND THE RESULT WAS REPORTED OUT UNDER THE INCORRECT PATIENT. CUSTOMER INDICATED THAT SHE VERIFIED PAPER PRINTOUT LABEL WITH THE RP 405 DISPLAY. CUSTOMER ALSO INDICATED THAT RESULTS WERE REPORTED TO THE PHYSICIAN BUT PHYSICIAN WAS NOTIFIED THAT RESULTS WERE INCORRECT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.