FDA.reportPublic FDA data

MAUDE MDR 4544523

MDR report key
4544523
Report number
1823260-2015-01524
Event key
0
Event type
3
Date of event
2015-01-29
Date received
2015-02-25
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
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1URISYS 1100AUTOMATED URINE ANALYZERROCHE DIAGNOSTICSKHENA03617556001NAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-02-250

Event Narratives#

D

Patient 1

PATIENT SAMPLE WAS TESTED ON THE URISYS 1100 WHICH REPORTED A NEGATIVE RESULT FOR LEUKOCYTES. THE SAME SAMPLE, WHEN TESTED ON AN UNSPECIFIED LABORATORY INSTRUMENT, REPORTED A RESULT OF 40 WBC/HPF. PATIENT WAS GIVEN ANTIBIOTICS FOR HER URINARY TRACT INFECTION. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

N

Patient 1

IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.