URISYS 1100 03617556001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-26 for URISYS 1100 03617556001 manufactured by Roche Diagnostics.

Event Text Entries

[4881159] Reporter stated that the urisys 1100 reported a value of negative for erythrocytes while a visual read of the test strip showed a value of 50 erythrocytes/microliter. No adverse event was reported. The manufacturer requested the return of the suspect product for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[12005743] It is not known if the initial reporter has or intends to report the event to fda the suspect product listed is the same suspect product reported on medwatch with patient identifier (b)(6).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2014-06502
MDR Report Key4036635
Report Source06
Date Received2014-08-26
Date of Report2014-09-30
Date of Event2014-07-21
Date Mfgr Received2014-07-30
Date Added to Maude2014-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameURISYS 1100
Generic NameAUTOMATED URINE ANALYZER
Product CodeKHE
Date Received2014-08-26
Model NumberNA
Catalog Number03617556001
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-26

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