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 2020-03-17 for ACCU-CHEK ? FASTCLIX manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[183887168] 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.
Patient Sequence No: 1, Text Type: N, H10


[183887169] It was reported that the lancet protrudes beyond the end cap of the device. Customer accidentally pricked herself on the protruding lancet. No medical attention needed, could help herself.
Patient Sequence No: 1, Text Type: D, B5


[187655819] 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


MAUDE Entry Details

Report Number3011393376-2020-00979
MDR Report Key9846008
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-17
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 Received2020-03-17
Lot NumberWPD049B
Device Expiration Date2019-07-31
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 2020-03-17

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