FDA.reportPublic FDA data

MAUDE MDR 7626779

MDR report key
7626779
Report number
2247117-2018-00050
Event key
0
Event type
3
Date of event
2018-05-29
Date received
2018-06-21
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SHWETA GULATI
Address
511 BENEDICT AVENUE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0VERSACELL X3 SAMPLE MANAGEMENT SYSTEMSAMPLE MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.JJEVERSACELL X3 SAMPLE MANAGEMENT SYSTEMN N
1VERSACELL X3 SAMPLE MANAGEMENT SYSTEMSAMPLE MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.DGCVERSACELL X3 SAMPLE MANAGEMENT SYSTEMN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-210

Event Narratives#

N

Patient 1

A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE LOG FILES AND DETERMINED THAT THE FIRST SAMPLE TUBE WAS PROPERLY SCANNED ON THE VERSACELL X3 SYSTEM. ACCORDING TO THE LOG FILES, THE VERSACELL X3 DRAWER CONTAINING THE SAMPLE IN QUESTION WAS UNLOCKED PRIOR TO THE POTASSIUM RERUN BEING ORDERED BY THE CENTRALINK DATA MANAGEMENT SYSTEM. TO PERFORM THE REFLEX CALCIUM AND REPEAT POTASSIUM REQUESTS, THE SAMPLE WAS REQUIRED TO BE PLACED BACK ON THE VERSACELL X3 SYSTEM. ACCORDING TO THE LOG FILES, THE SAMPLE TUBE WAS NOT FOUND ON THE VERSACELL X3 SYSTEM UNTIL (B)(6) 2018. AT THAT POINT, THE SAMPLE WAS PROCESSED FOR REPEAT POTASSIUM AND REFLEX CALCIUM. THE REVIEW OF LOG FILES INDICATED THAT THE SAMPLE IN QUESTION WAS REMOVED FROM THE VERSACELL X3 SYSTEM ON (B)(6) 2018, AFTER THE INITIAL RUN FOR POTASSIUM WAS PROCESSED AND REINTRODUCED THE NEXT DAY ((B)(6) 2018) ON THE VERSACELL X3 SYSTEM. THE HSC SPECIALIST CONCLUDED THAT THE VERSACELL X3 SYSTEM WAS PERFORMING AS EXPECTED WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. WE ARE SUBMITTING THIS REPORT IN AN EXCESS OF CAUTION. THE INITIAL RESULT WAS TRANSMITTED TO THE CENTRALINK DATA MANAGEMENT SYSTEM ON (B)(6) 2018 WITHOUT ANY ISSUE AND THE RESULT WAS AVAILABLE ON THE LABORATORY INFORMATION SYSTEM (LIS) TO BE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER WAS AWARE THAT THE INITIAL RESULT WAS AVAILABLE BOTH ON THE ANALYZER AND AVAILABLE ON CENTRALINK. IT IS SIEMENS' UNDERSTANDING THAT POTASSIUM VALUES GREATER THAN 5.5 MMOL/L ARE GENERALLY CONSIDERED INDICATIVE OF A HYPERKALEMIC EMERGENCY (I.E. PANIC VALUE/CRITICAL CALL VALUE) REQUIRING IMMEDIATE ACTION TO LOWER POTASSIUM VALUES. IT IS OUR UNDERSTANDING THAT GOOD LABORATORY PRACTICE DICTATES THAT LABORATORIES HAVE PROCEDURES IN PLACE TO ENSURE THAT PROVIDERS ARE PROMPTLY NOTIFIED OF A PANIC RESULT. THIS EVENT INVOLVES A DELAY IN RESULTS FOR A REPEAT POTASSIUM AND REFLEXED CALCIUM. THIS DELAY WOULD HAVE BEEN APPARENT TO THE LABORATORY THROUGH TEST PENDING LOGS AND/OR METHODS/PROCEDURES USED TO MONITOR LABORATORY TURN-AROUND-TIME. THE DEVICE IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS.

D

Patient 1

THE CUSTOMER REPORTED THAT THE RERUN FOR POTASSIUM TESTING WAS DELAYED FOR A PATIENT SAMPLE. ON (B)(6) 2018, THE PATIENT SAMPLE WAS INITIALLY LOADED ON A VERSACELL X3 SAMPLE MANAGEMENT SYSTEM AND PROCESSED ON AN ADVIA 1800 INSTRUMENT. BECAUSE THE POTASSIUM RESULT FOR THE INITIAL PATIENT SAMPLE WAS GREATER THAN 5.5 MMOL/L, A REQUEST FOR A POTASSIUM RERUN AND REFLEX CALCIUM WAS SENT TO THE VERSACELL X3 SYSTEM ON THE SAME DAY. THE CUSTOMER HAS CONFIRMED THAT THERE WAS NO DISCORDANT RESULT FOR THE INITIAL SAMPLE AND THAT THE REPEAT POTASSIUM WAS CORRECT. THE INITIAL SAMPLE WAS PROCESSED ON (B)(6) 2018 ON THE ADVIA 1800 INSTRUMENT. THE SAME SAMPLE WAS REPEATED ON THE NEXT DAY ((B)(6) 2018) AND WAS REPORTED BY THE LABORATORY STAFF TO THE CLINICAL STAFF ON THE MORNING OF (B)(6) 2018. THE CUSTOMER REQUESTED THAT THE RERUN DELAY BE INVESTIGATED . THE PATIENT EXPIRED. WE ARE NOT AWARE OF ANY INFORMATION TO SUGGEST THAT THE PHYSICIAN ATTRIBUTED THE PATIENT DEATH TO THE DELAY IN REPORTING. STATEMENTS ATTRIBUTED TO THE PHYSICIAN AND CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED.