ACCU-CHEK ? RAPIDLINK INFUSION SET

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 2020-03-30 for ACCU-CHEK ? RAPIDLINK INFUSION SET manufactured by Roche Diabetes Care, Inc..

Event Text Entries

[185673823] 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. It was reported this issue only occurred with one lot/pack of infusion sets, however two different lot numbers ( 32134189 and 32174299) of infusion sets were logged on the case. Therefore, using the lot of asku, since we are unable to determine which lot produced the leak at this time.
Patient Sequence No: 1, Text Type: N, H10


[185673824] It was reported that one pack of infusion sets was leaking at the headset. Lots 32134189 and 32174299 were reported. It is unknown which lot is alleged to have leaked.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011393376-2020-01214
MDR Report Key9898718
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-24
Date Mfgr Received2020-03-24
Date Added to Maude2020-03-30
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 G1FRESENIUS KABI DEUTSCHLAND GMBH
Manufacturer StreetROBERT-KOCH-STRASSE 5 NA
Manufacturer CityBAD HERSFELD D-36251
Manufacturer CountryGM
Manufacturer Postal CodeD-36251
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACCU-CHEK ? RAPIDLINK INFUSION SET
Generic NameSUBCUTANEOUS INFUSION SET
Product CodeFPA
Date Received2020-03-30
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 2020-03-30

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