FDA.reportPublic FDA data

MAUDE MDR 9738950

MDR report key
9738950
Report number
1000515253-2020-00006
Event key
0
Event type
3
Date of event
2020-01-24
Date received
2020-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. NANCY GOULD
Address
577 APTAKISIC RD LINCOLNSHIRE, IL US
Phone
543-543-5439
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSMEX XE-5000AUTOMATED HEMATOLOGY ANALYZERSYSMEX CORPORATIONGKZXE-500006375917N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2101. O

Event Narratives#

N

Patient 1

SEVERAL PREVIOUS SAMPLES WERE REPORTED TO HAVE PLT CLUMPS PRESENT BASED ON SMEAR REVIEWS. THE SAMPLE ANALYSIS FROM (B)(6) 2020 WAS NOT CONFIRMED WITH ADDITIONAL REVIEW. IT IS UNKNOWN IF PLT CLUMPING WAS PRESENT. THE XE-5000 SOFTWARE GUIDE (SG), CHAPTER 6 - APPENDIX, SECTION 6.1 - IP MESSAGES, DISCUSSES THE MANUFACTURER-RECOMMENDED SETTING FOR THE THROMBOCYTOPENIA FLAG, WHICH IS A PLT OF

D

Patient 1

AN OPERATOR ANALYZED A PATIENT SAMPLE ON (B)(6) 2020 AND A LOW PLATELET (PLT) RESULT WAS GENERATED. THE RESULT WAS REPORTED TO THE MEDICAL TEAM AND THE PATIENT WAS ADMINISTERED A PLT TRANSFUSION. BETWEEN (B)(6) 2020, THE PATIENT HAD NEW SAMPLES COLLECTED WHICH GENERATED LOW PLT RESULTS. ON (B)(6) 2020, A NEW SAMPLE WAS COLLECTED AND ANALYZED. A PLT RESULT WITHIN THE NORMAL RANGE WAS GENERATED. THE OPERATOR PERFORMED A SMEAR REVIEW AND PLT CLUMPS WERE OBSERVED. DUE TO THE PRESENCE OF PLT CLUMPS ON THIS SAMPLE, THE OPERATOR SUSPECTED THE SAMPLE ANALYZED ON (B)(6) 2020 TO HAVE AN ERRONEOUS LOW PLT RESULT. THERE WAS NO HARM TO THE PATIENT REPORTED DUE TO THE PLT TRANSFUSION.