CHEMSTRIP? 10 UA 11895354160

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 2012-07-25 for CHEMSTRIP? 10 UA 11895354160 manufactured by Roche Diagnostics.

Event Text Entries

[2841069] The initial result was "negative" for leukocytes on the chemstrip 10 ua. The result from the iris lab instrument came up as 1+ which is 250-500 leukocytes per microliter. The patient has been discharged from the hospital. The caller did not have any specific patient treatment information. No actions were reported taken based on either test. A request was made for the return of the meter and strips.
Patient Sequence No: 1, Text Type: D, B5


[10073024] .
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2012-03823
MDR Report Key2669034
Report Source06
Date Received2012-07-25
Date of Report2012-08-24
Date of Event2012-07-10
Date Mfgr Received2012-07-17
Device Manufacturer Date2011-10-13
Date Added to Maude2012-07-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactNA JENNIFER WOLFGRAM
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175217008
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCHEMSTRIP? 10 UA
Generic NameMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
Product CodeLJX
Date Received2012-07-25
Model NumberNA
Catalog Number11895354160
Lot Number21155101
ID NumberNA
Device Expiration Date2013-04-30
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 2012-07-25

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