ACCU-CHEK ? GUIDE TEST STRIPS 07453736001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for ACCU-CHEK ? GUIDE TEST STRIPS 07453736001 manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[185921734] It was reported the patient received the following results within 15 minutes: 300 mg/dl and 120 mg/dl on two different meters using the same vial of test strips.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011393376-2020-01246
MDR Report Key9906915
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-25
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-31
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 FDA3
Event Location3
Manufacturer ContactNA GREG SMITH
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 462500457
Manufacturer CountryUS
Manufacturer Postal462500457
Manufacturer Phone3175212484
Manufacturer G1ROCHE DIABETES CARE, INC.
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 462501025
Manufacturer CountryUS
Manufacturer Postal Code462501025
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCU-CHEK ? GUIDE TEST STRIPS
Generic NameBLOOD GLUCOSE MONITORING TEST STRIPS
Product CodeNBW
Date Received2020-03-31
Model Number07453736001
Catalog Number07453736001
Lot Number101299
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeNULL
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIABETES CARE, INC.
Manufacturer Address9115 HAGUE ROAD INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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