IMMULITE THYROGLOBULIN KIT LKTY1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2000-12-15 for IMMULITE THYROGLOBULIN KIT LKTY1 manufactured by Diagnostic Products Corporation.

Event Text Entries

[215090] Distributor reported that a customer reported obtaining spuriously high results with this kit. Subsequently, the pt was treated, although later investigation determined that this treatment was not necessary. Treatment was not a serious injury, however, it could possibly have been under different circumstances.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017183-2000-00001
MDR Report Key309279
Report Source01,08
Date Received2000-12-15
Date of Report2000-12-14
Date of Event2000-11-14
Date Mfgr Received2000-11-14
Device Manufacturer Date2000-03-01
Date Added to Maude2000-12-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street5700 WEST 96TH STREET
Manufacturer CityLOS ANGELES CA 90045
Manufacturer CountryUS
Manufacturer Postal90045
Manufacturer Phone3106458200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRB
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE THYROGLOBULIN KIT
Generic NameIN-VITRO DIAGNOSTIC TEST KIT
Product CodeMSW
Date Received2000-12-15
Model NumberNA
Catalog NumberLKTY1
Lot Number216
ID NumberNA
Device Expiration Date2001-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key299239
ManufacturerDIAGNOSTIC PRODUCTS CORPORATION
Manufacturer Address5700 WEST 96TH STREET LOS ANGELES CA 90045 US
Baseline Brand NameIMMULITE THYROGLOBULIN KIT
Baseline Generic NameIN-VITR DIAGNOSTIC TEST KIT
Baseline Model NoNA
Baseline Catalog NoLKTY1
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2000-12-15

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