FDA.reportPublic FDA data

MAUDE MDR 7705720

MDR report key
7705720
Report number
9610806-2018-00074
Event key
0
Event type
3
Date of event
2018-06-25
Date received
2018-07-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CHRISTINA LAM
Address
511 BENEDICT AVE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BCS XP SYSTEMBCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHGKPBCS XP SYSTEM10459330N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-200

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER DETERMINED THAT BOTH SAMPLES WERE PALE YELLOW AND CLEAR AND THAT THE SAMPLES TUBES WERE CORRECTLY FILLED. THE CUSTOMER INDICATED THAT THE SYRINGES, PRIMES AND PIPETTORS ON THE SYSTEM WERE RECOVERING ACCEPTABLY. THEY ALSO REPORTED THAT THEY RAN A VALIDATION KIT ON THE SYSTEM, WHICH RECOVERED ACCEPTABLY. THERE WAS NO RECURRENCE OF THIS ISSUE WITH OTHER SAMPLES AND SIEMENS DETERMINED THAT THE SAMPLE INTEGRITY AND TUBE TYPE WERE ACCEPTABLE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. AS PER THE CUSTOMER'S REQUEST, THE CSE PROACTIVELY REPLACED AND ALIGNED THE REAGENT AND SAMPLE PROBES AND CALIBRATED THE PISTON PUMPS AND REAGENT PROBE TEMPERATURE. THE CUSTOMER INFORMED THE CSE THAT THE FLAGGED RESULTS WERE PRODUCED AS A RESULT OF IMPROPER SAMPLE CENTRIFUGATION. SIEMENS FURTHER INVESTIGATED THE EVENT AND DETERMINED THAT THERE WAS NO SYSTEM OR REAGENT MALFUNCTION. SIEMENS DETERMINED THAT THE RESULTS WERE FLAGGED APPROPRIATELY AND THAT QUALITY CONTROLS (QCS) WERE WITHIN ACCEPTABLE RANGES ON THE DAY OF THE EVENT. LOW FIBRINOGEN, CLOTS IN THE SAMPLE, OR A CLOGGED SAMPLE PROBE POTENTIALLY CAUSED THE FLAGS TO BE TRIGGERED ON THE AFFECTED SAMPLE. INADEQUATE MIXING, CENTRIFUGATION AND OTHER MISHANDLING OF THE SAMPLE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE FLAGGED RESULTS. AS PER THE "EVALUATION AND CHECKING METHODS FOR INTERPRETATION OF MEASUREMENT CURVES ON THE BCS SYSTEM/BCS XP SYSTEM" BULLETIN, RESULTS FLAGGED WITH "MEASUREMENT CURVE WITHOUT REACTION" ERRORS ARE NOT TO BE REPORTED AS GREATER THAN OR LESS THAN THE REPORTING LIMIT. SIEMENS DETERMINED THE CUSTOMER INCORRECTLY REPORTED THE RESULTS AND DID NOT ADEQUATELY FOLLOW THE INSTRUCTIONS DOCUMENTED IN THE BULLETIN. SIEMENS EDUCATED THE CUSTOMER ON HOW TO REVIEW REACTION CURVES AND INFORMED THE CUSTOMER THAT THE RESULTS OBTAINED ON THE AFFECTED SAMPLE WERE NOT REPORTABLE. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

D

Patient 1

A FLAGGED PROTHROMBIN TIME (PT) RESULT OF "NO REACTION" WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM. THE SAMPLE WAS REPEATED TWICE, IN EXTENDED TIME, ON THE SAME SYSTEM, RESULTING IN "NO REACTION". THE CUSTOMER BELIEVED THAT THE PATIENT RECOVERY WAS >200 SECONDS (>19 INTERNATIONAL NORMALIZED RATIO [INR]) FROM THE RESULTS OBTAINED ON THE BCS XP SYSTEM AND REPORTED THESE RESULTS TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLE WAS RERUN ON AN ALTERNATE NON-SIEMENS SYSTEM, USING THE SAME DADE INNOVIN REAGENT LOT, RECOVERING IN A RESULT OF 10.1 SECONDS. THE SAMPLE WAS RE-CENTRIFUGED AND RE-RUN ON THE INITIAL SYSTEM, RECOVERING LOWER THAN THE REPORTED RESULT. THE RESULT OBTAINED ON THE INITIAL SYSTEM, AFTER THE SAMPLE WAS RE-CENTRIFUGED, WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON THE INITIAL BCS XP SYSTEM; A PT RESULT OF 10.8 SECONDS WAS OBTAINED ON THE NEW SAMPLE. THIS RESULT WAS ALSO REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT AND PT INR RESULTS REPORTED ON THE PATIENT SAMPLE.