VITROS CHEMISTRY PRODUCTS LITHIUM SLIDES 1632660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2004-02-20 for VITROS CHEMISTRY PRODUCTS LITHIUM SLIDES 1632660 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[335616] The customer obtained biased pt results for lithium slides following failed quality control results. Correct results were obtained upon retesting qc and pt sample with a fresh lithium slide cartridge. Biased results of this type may initiate inappropriate physician action. No results reported and there was no report of pt harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319681-2004-00030
MDR Report Key525541
Report Source01,05
Date Received2004-02-20
Date of Report2004-01-10
Date of Event2004-01-10
Date Mfgr Received2004-01-10
Device Manufacturer Date2003-06-01
Date Added to Maude2004-05-20
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 Location0
Manufacturer ContactTHOMAS SMITH
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 146265101
Manufacturer CountryUS
Manufacturer Postal146265101
Manufacturer Phone5854533735
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS LITHIUM SLIDES
Generic NameIN VITRO DIAGNOSTIC
Product CodeJII
Date Received2004-02-20
Model NumberNA
Catalog Number1632660
Lot Number3111-0054-2970
ID NumberNA
Device Expiration Date2005-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key514676
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DR. ROCHESTER NY 146265101 US
Baseline Brand NameVITROS CHEMISTRY PRODUCTS LITHIUM SLIDES
Baseline Generic NameIN VITRO DIAGNOSTIC
Baseline Model NoNA
Baseline Catalog No1632660
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2004-02-20

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