ACCU-CHEK ? LINKASSIST PLUS INSERTION DEVICE

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 2020-03-31 for ACCU-CHEK ? LINKASSIST PLUS INSERTION DEVICE manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[185922009] It was reported that the insertion device ejected the infusion set unintentionally. No adverse event reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011393376-2020-01248
MDR Report Key9907196
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-27
Date Mfgr Received2020-03-27
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 G1BALDA MEDICAL GMBH & CO. KG
Manufacturer StreetBERGKICHENER STR. 228 NA
Manufacturer CityBAD OEYNHAUSEN 32549
Manufacturer CountryGM
Manufacturer Postal Code32549
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCU-CHEK ? LINKASSIST PLUS INSERTION DEVICE
Generic NameSPRING LOADED INSERTION DEVICE
Product CodeKZH
Date Received2020-03-31
Lot NumberASKU
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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