ACCU-CHEK ? FASTCLIX 05864666160

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 2020-02-24 for ACCU-CHEK ? FASTCLIX 05864666160 manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[180565109] It was reported that the lancet protrudes beyond the end cap of the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011393376-2020-00696
MDR Report Key9744723
Report SourceCONSUMER
Date Received2020-02-24
Date of Report2020-03-18
Date of Event2020-01-28
Date Mfgr Received2020-03-10
Date Added to Maude2020-02-24
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 Received2020-02-24
Returned To Mfg2020-03-09
Catalog Number05864666160
Lot Number33319097
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
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 2020-02-24

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