BD PARADIGM LINK GLUCOSE MONITOR 322201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2004-09-10 for BD PARADIGM LINK GLUCOSE MONITOR 322201 manufactured by Becton Dickinson.

Event Text Entries

[36097149] Awaiting product return to conduct quality investigation.
Patient Sequence No: 1, Text Type: N, H10


[36097150] Consumer called to report his meter is giving inaccurate readings. Analysis run on clark error grid using mean avg. Reading (62) as ref. Point vs. Bd readings (25, 99) yielded data points in the d range of the grid, outside of acceptable limits.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243072-2004-00544
MDR Report Key5351791
Report SourceCONSUMER
Date Received2004-09-10
Date of Report2004-09-10
Date of Event2004-08-11
Date Mfgr Received2004-08-11
Device Manufacturer Date2003-04-01
Date Added to Maude2016-01-07
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 ContactSALLY THOMSON
Manufacturer Street1 BECTON DR.
Manufacturer CityFRANKLIN LAKES NJ 07417
Manufacturer CountryUS
Manufacturer Postal07417
Manufacturer Phone2018474838
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD PARADIGM LINK GLUCOSE MONITOR
Generic NameBD TEST STRIPS
Product CodeFJD
Date Received2004-09-10
Model NumberNA
Catalog Number322201
Lot Number3064100
Device Expiration Date2005-10-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON
Manufacturer Address1 BECTON DR. FRANKLIN LAKES NJ 07417 US 07417


Patients

Patient NumberTreatmentOutcomeDate
10 2004-09-10

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