ALINITY I FERRITIN 07P65-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-20 for ALINITY I FERRITIN 07P65-30 manufactured by A.i.d.d Longford.

Event Text Entries

[131894393] A product recall letter was issued to customers who received shipments of the affected alinity reagents to inform them of the manufacturing issue identified with the reagent cartridge bottle necks. The letter instructs the customer to manually inspect each reagent cartridge in inventory before use. Stat assays, alinity i stat high sensitive troponin- i and alinity i total b-hcg, should be inspected first as a priority to ensure no delay in testing for those assays. Removals and corrections report number: 3005094123-11/21/18-002-r.
Patient Sequence No: 1, Text Type: N, H10


[131894394] The customer observed error code 5817 (unable to initialize module due to previous load or unload error. Remove reagent cartridge or rack with load or unload error from reagent carousel) while loading alinity i ferritin reagent lot 93238ui00 on the alinity i processing module. There was no report of any patient impact due to the potential delay in generating ferritin results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005094123-2018-00263
MDR Report Key8186942
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-12-20
Date of Report2018-12-20
Date of Event2018-11-22
Date Mfgr Received2018-12-06
Device Manufacturer Date2018-11-02
Date Added to Maude2018-12-20
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 ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224667-512
Manufacturer G1A.I.D.D LONGFORD
Manufacturer StreetLISNAMUCK CO. LONGFORD
Manufacturer CityLONGFORD NA
Manufacturer CountryEI
Manufacturer Postal CodeNA
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number3005094123-11/21/18-002R
Event Type3
Type of Report3

Device Details

Brand NameALINITY I FERRITIN
Generic NameFERRITIN
Product CodeDBF
Date Received2018-12-20
Catalog Number07P65-30
Lot Number93238UI00
Device Expiration Date2019-09-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerA.I.D.D LONGFORD
Manufacturer AddressLISNAMUCK CO. LONGFORD LONGFORD NA EI NA


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.