ACCU-CHEK ? FASTCLIX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-18 for ACCU-CHEK ? FASTCLIX manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[180402051] The event occurred outside of the united states. While this product is not sold in the united states, it is like or similar to a product marketed in the united states. The year is the only known part of manufacture date. We have defaulted to the first of the year.
Patient Sequence No: 1, Text Type: N, H10


[180402052] Upon review by the manufacturer's investigation unit, the lancet protrudes beyond the end cap of the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011393376-2020-00649
MDR Report Key9722512
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-18
Date of Report2020-02-18
Date of Event2020-02-12
Date Mfgr Received2020-02-12
Device Manufacturer Date2015-01-01
Date Added to Maude2020-02-18
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 G1GERRESHEIMER REGENSBURG GMBH
Manufacturer StreetHIRTENSTRASSE 50 NA
Manufacturer CityPFREIMD 92536
Manufacturer CountryGM
Manufacturer Postal Code92536
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCU-CHEK ? FASTCLIX
Generic NameLANCET DEVICE
Product CodeFMK
Date Received2020-02-18
Returned To Mfg2020-02-12
Lot NumberGDC187
Device AvailabilityR
Device AgeNULL
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIABETES CARE, INC.
Manufacturer Address9115 HAGUE ROAD INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-18

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