FDA.reportPublic FDA data

MAUDE MDR 9746469

MDR report key
9746469
Report number
3002637618-2020-00006
Event key
0
Event type
3
Date of event
2020-01-30
Date received
2020-02-24
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
FELIX AKINRINOLA
Address
2 EDGEWATER DRIVE NORWOOD, MA US
Phone
705-705-7052
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RAPIDPOINT 500 BLOOD GAS ANALYZERRP 500SIEMENS HEALTHCARE DIAGNOSTICSCHL10697306Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-240

Event Narratives#

N

Patient 1

THE CUSTOMER STATED THAT THIS LOW THB RESULT WAS NOT REPORTED SO THE PATIENT'S TREATMENT WAS NOT AFFECTED. ALSO STATED WAS IRREGULARITIES WERE OBSERVED IN THE SAMPLE COLLECTION PROCESS SUCH AS IMPROPERLY MIXED SAMPLES. IN THE EVENTS LOG, THERE WERE SEVERAL "D39 CLOT DETECTED" ERRORS FOUND. THE LOG FILES WERE RECEIVED FOR INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN.

D

Patient 1

THE CUSTOMER REPORTED AN UNUSUALLY LOW TOTAL HEMOGLOBIN RESULT ON THE RP 500. THE CUSTOMER DID NOT REPEAT THE TEST AND STATED THE RESULT WAS EXPECTED TO BE THE NORMAL RANGE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.