HEMOSIL VON WILLEBRAND FACTOR ACTIVITY 0020004700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-05-24 for HEMOSIL VON WILLEBRAND FACTOR ACTIVITY 0020004700 manufactured by Instrumentation Laboratory Co..

Event Text Entries

[21289930] Customer stated they are a reference lab using a sta-r evolution instrument with vwf activity part number 20004700, lot b11498. They have 4 samples that were verified as erroneous by an alternate method.
Patient Sequence No: 1, Text Type: D, B5


[21351718] This product lot number, b11498, is under recall action and is on file with the fda as a class ii action (reference z-1519-2012). The customer had not received the recall notification at the time of the incident and has since received the notification and followed the necessary actions. Per the customer, no pt treatment or adverse events were involved with this complaint. Further, (b)(4) makes no claim for performance of this reagent on a non-il analyzer which the customer was using.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1217183-2012-00008
MDR Report Key2593700
Report Source05,08
Date Received2012-05-24
Date of Report2012-05-24
Date of Event2012-04-16
Device Manufacturer Date2011-02-25
Date Added to Maude2012-08-01
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 FDA0
Event Location0
Manufacturer ContactCAROL MARBLE
Manufacturer Street180 HARTWELL ROAD
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal01730
Manufacturer Phone7818614467
Manufacturer G1INSTRUMENTATION LABORATORY CO.
Manufacturer Street180 HARTWELL ROAD
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal Code01730
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMOSIL VON WILLEBRAND FACTOR ACTIVITY
Generic NameFACTOR DEFICIENCY TEST
Product CodeGGP
Date Received2012-05-24
Model NumberNA
Catalog Number0020004700
Lot NumberB11498
Device Expiration Date2012-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINSTRUMENTATION LABORATORY CO.
Manufacturer Address180 HARTWELL ROAD BEDFORD MA 01730 US 01730


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-24

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