FDA.reportPublic FDA data

MAUDE MDR 7266710

MDR report key
7266710
Report number
9610806-2018-00025
Event key
0
Event type
3
Date of event
2017-11-16
Date received
2018-02-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1BN PROSPEC SYSTEMBN PROSPEC SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHJZWBN PROSPEC SYSTEM10461865N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-130

Event Narratives#

N

Patient 1

SIEMENS HEALTHCARE DIAGNOSTICS (SIEMENS) ANALYZED THE KINETIC CURVES TO DETERMINE THE CAUSE OF THE DISCORDANT, FALSELY LOW RESULTS OBTAINED ON THE PATIENT SAMPLE ON THE BN PROSPEC SYSTEM AND DETERMINED THAT TURBIDITY, NOT DUE TO THE SAMPLE REACTION, POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULTS. THIS WAS POTENTIALLY CAUSED BY INSUFFICIENT CENTRIFUGATION OF THE SAMPLE PRIOR TO RUNNING THE SAMPLE. UPON FURTHER INVESTIGATION, SIEMENS DETERMINED THAT A SAMPLE SPECIFIC OR PRE-ANALYTICAL ISSUE POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULTS SINCE DISCORDANT RESULTS WERE OBTAINED FOR MULTIPLE ASSAYS ON THE AFFECTED SAMPLE. SIEMENS ALSO DETERMINED THAT THE OPERATOR CENTRIFUGED SAMPLES AT A SUFFICIENT TIME AND SPEED, BUT RECOMMENDED THAT THE OPERATOR INCREASE THEIR CENTRIFUGE TIME. SIEMENS PROVIDED A TABLE WITH RECOMMENDED SAMPLE STORAGE TIME, FOR EACH ASSAY, TO THE OPERATOR. ON (B)(6) 2018, THE OPERATOR INFORMED SIEMENS THAT THEY INCREASED THEIR CENTRIFUGE TIME AND REPORTED THAT THEY OBTAINED IMPRECISE A1-ANTITRYPSIN AND IMMUNOGLOBULIN M (IGM) RESULTS ON RIQAS PROFICIENCY TESTING SAMPLES. THE OPERATOR INDICATED THAT THEY WERE RUNNING PATIENT SAMPLES AND QUALITY CONTROLS ROUTINELY AND QUALITY CONTROLS WERE RECOVERING WITHIN EXPECTED RANGES. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST ANALYZED THE BN PROSPEC SYSTEM FILES TO DETERMINE THE CAUSE OF THE IMPRECISE A1-ANTITRYPSIN AND IGM RESULTS OBTAINED ON THE RIQAS PROFICIENCY TESTING SAMPLES AND FOUND NO ISSUE. THE HSC SPECIALIST INDICATED THAT THE KINETIC CURVES RECOVERED AS EXPECTED AND THAT THE BIT VALUES FOR THESE ASSAYS CORRELATED TO THE CONCENTRATION RESULTS. THERE WERE NO ERRORS IN THE ERROR LOG FILES THAT POTENTIALLY CONTRIBUTED TO THE IMPRECISE RESULTS. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED. THE OPERATOR REPORTED THAT TWO PATIENT SAMPLES (SAMPLE ID (B)(6)) WERE IMPACTED BY THIS EVENT. MDR 9610806-2018-00024 WAS FILED FOR SAMPLE ID (B)(6) AND MDR 9610806-2018-00025 WAS FILED FOR SAMPLE ID (B)(6).

D

Patient 1

DISCORDANT, FALSELY LOW IMMUNOGLOBULIN G (IGG), IMMUNOGLOBULIN A (IGA), IMMUNOGLOBULIN M (IGM), KAPPA, LAMBDA, HAPTOGLOBIN AND BETA 2- MICROGLOBULIN RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC SYSTEM. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RERUN ON THE SAME SYSTEM, RESULTING HIGHER THAN THE INITIAL RESULTS. THE REPEAT RESULTS WERE THE CORRECT RESULTS AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW IGG, IGA, IGM, KAPPA, LAMBDA, HAPTOGLOBIN AND BETA 2- MICROGLOBULIN RESULTS.