FDA.reportPublic FDA data

MAUDE MDR 1667015

MDR report key
1667015
Report number
1823260-2010-02469
Event key
0
Event type
3
Date of event
2010-04-08
Date received
2010-04-26
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 ERIC KOLODZIEJ
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
12010-04-260

Event Narratives#

D

Patient 1

THE USER RECEIVED A NEGATIVE RESULT FOR LEUKOCYTES WITH THE MICROSCOPIC RESULT OF > 100 WBCS/HPF. THE USER RETESTED WITH A NEW VIAL OF STRIPS, SAME LOT NUMBER, AND GOT A RESULT OF 2+ FOR LEUKOCYTES. THE USER TRIED A THIRD VIAL AND RECEIVED A NEGATIVE RESULT FOR LEUKOCYTES. THE PATIENT WAS NOT TREATED OR ADVERSELY AFFECTED DUE TO THE ERRONEOUS RESULTS. THE REAGENT STRIP LOT NUMBER WAS 23052942.

D

Patient 1

PER THE CLINIC, THE PATIENT EXPERIENCED RECURRING INFECTIONS AT THE IMPLANT SITE. THE DEVICE WAS EXPLANTED (B)(6) 2010, AND THERE ARE NO PLANS TO REIMPLANT AS OF THE DATE OF THIS REPORT.

D

Patient 1

CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE AFTER FIRING. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

N

Patient 1

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

N

Patient 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. CORRECTION BEING SENT. DEVICE WAS NOT RETURNED FOR EVALUATION.