FDA.reportPublic FDA data

MAUDE MDR 1977673

MDR report key
1977673
Report number
1823260-2011-00553
Event key
0
Event type
3
Date of event
2010-11-08
Date received
2011-02-03
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 RICHEAL CLINE
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 DIAGNOSTICSKHENA03617556690NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-030

Event Narratives#

N

Patient 1

THE URISYS 1100 METER WAS RETURNED FOR INVESTIGATION. THE METER AS WELL AS A URISYS 1100 FROM THE INVESTIGATIONAL UNIT WERE CHECKED WITH 0- ARTIFICIAL URINE, 0-NATIVE URINE, AND A LEUKOCYTE DILUTION SERIES. ALL RESULTS WERE WITHIN THE SPECIFIED RANGES. IT WAS DETERMINED THE RETURNED METER PERFORMED WITHIN SPECIFICATION AND NO MALFUNCTION WAS OBSERVED. AS THE USER DID NOT RETURN THE AFFECTED TEST STRIPS NOR PROVIDE THE LOT NUMBER, FURTHER INVESTIGATION COULD NOT BE PERFORMED.

D

Patient 1

THE USER RECEIVED A QUESTIONABLE LEUKOCYTE RESULT FOR ONE PATIENT SAMPLE. THE INSTRUMENT READ THE STRIP AS NEGATIVE AND THE LEUKOCYTE RESULT BY VISUAL READING WAS 100 (NO UNIT OF MEASURE WAS PROVIDED). A MICROSCOPIC ANALYSIS WAS DONE AND CONFIRMED THE POSITIVE VISUAL READING AT 14-15 WHITE BLOOD CELLS. NO ADVERSE EVENTS WERE ALLEGED. THE LOT NUMBER OF THE CHEMSTRIP 10 MD URINE TEST STRIPS WAS NOT PROVIDED.

N

Patient 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.