VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-19 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[4694956] The customer observed lower than expected vitros gent results on three different quality control fluids processed on a vitros 5,1fs chemistry system using vitros gent reagent, lot 1512-09-3511 tdm lev i vitros gent= 0. 763 and 0. 739 versus expected 2. 73 ug/ml biorad lev 2 vitros gent= 3. 4 versus expected 5. 3 ug/ml biorad lev 3 vitros gent = 5. 0 versus expected 7. 9 ug/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. However, no vitros gent patient sample results were questioned. There was no allegation of patient harm as a result of this event. This report is number one of three mdr? S for this event. Three 3500a forms are being submitted for this event as three devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11985214] The investigation determined that non-reproducible vitros gent results were obtained on three different quality control fluids processed on a vitros 5,1fs chemistry system. The most likely cause for this event is related to vitros gent reagent lot 1512-09-3511, as non-reproducible lower than expected results were obtained using three particular reagent packs from lot 1512-09-3511. There is no indication that the vitros 5,1fs instrument issue contributed to the event. The assignable cause for the event is related to vitros gent reagent lot 1512-09-3511.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319808-2014-00019
MDR Report Key4021394
Report Source05
Date Received2014-08-19
Date of Report2014-08-19
Date of Event2014-07-22
Date Mfgr Received2014-07-22
Device Manufacturer Date2013-11-01
Date Added to Maude2014-09-04
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 ContactMR. JAMES A STEVENS
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO-CLINICAL DIAGNOSTICS
Manufacturer Street1000 LEE ROAD
Manufacturer CityROCHESTER NY 14606
Manufacturer CountryUS
Manufacturer Postal Code14606
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS GENT REAGENT
Generic NameIN-VITRO DIAGNOSTIC
Product CodeLCD
Date Received2014-08-19
Catalog Number6801711
Lot Number1512-09-3511
Device Expiration Date2015-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-19

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