FDA.reportPublic FDA data

MAUDE MDR 501665

MDR report key
501665
Report number
MW1030513
Event key
0
Event type
3
Date received
2003-12-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
105
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYPOGUARDDIASCREEN 50 URINE DIPSTICKS READERHYPOGUARDKQO501242-00*NY
2HYPOGUARDREAGENT STRIPSHYPOGUARDCDM***NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-12-1001. O

Event Narratives#

D

Patient 1

FALSE POSITIVE LEUKOCYTES, NITRITES AND BILIRUBIN ON HYPOGUARD DIASCREEN (50) URINE DIPSTICK READER/HYPOGUARD REAGENT STRIPS. COMPANY HAS RESOLVED NITRITE PROBLEM AND HAS FINALLY ADMITTED TO LEUKOCYTE FALSE POSITIVES AND HAS COME OUT WITH NEW AND IMPROVED LEUKOCYTE REAGENT STRIPS BUT WILL NOT TAKE BAD STRIPS OFF THE MARKET BY RECALLING THEM, EVEN THOUGH THEY HAVE PROVEN THEY ARE DEFECTIVE. AFTER MUCH EFFORT, ON RPTR'S PART. REPORTER CANNOT GET COMPANY TO DO ANYTHING ABOUT FALSE POSITIVE BILIRUBINS. THEY CALLED REPORTER 12/03 AND SAID THEY COULD NOT DO ANYTHING MORE EVEN THOUGH REPORTER PROVED TO THEM REPORTER IS GETTING 8-9% FALSE POSITIVES AND THEY ARE SAYING REPORTER SHOULD ONLY HAVE 1-4% FALSE POSITIVE. REPORTER FEELS THESE STRIPS SHOULD BE IMPROVED OR BE REMOVED FROM MARKET.