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 2013-11-08 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[3846352] A customer observed multiple reproducible, lower than expected vitros gent quality control results on a single level of quality control fluid (biorad level 3 = 5. 07, 3. 53, 4. 65, 5. 47 and 5. 38 ug/ml vs. An expected result of 8. 02 ug/ml) on a vitros 5600 integrated system. The customer made no allegations that patient sample results were affected. However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected. There was no allegation of patient harm. 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11212535] The investigation determined that multiple reproducible, lower than expected vitros gent quality control results were obtained on a vitros 5600 integrated system. The investigation was unable to determine a definitive root cause. However, an instrument or reagent related issue, the biorad quality control fluids in use at the time of the event, or improper reagent or control fluid handling protocol cannot be ruled out as potential contributing factors. Expected quality control results were obtained following ocd field service and following ocd and biorad recommended reagent and fluid handling protocols. The customer and ocd are continuing to monitor vitros gent performance. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319808-2013-00048
MDR Report Key3457718
Report Source05
Date Received2013-11-08
Date of Report2013-11-08
Date of Event2013-10-10
Date Mfgr Received2013-10-10
Device Manufacturer Date2012-05-29
Date Added to Maude2014-02-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. JOSEPH FALVO
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 Received2013-11-08
Catalog Number6801711
Lot Number1512-08-2210
Device Expiration Date2014-02-28
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 2013-11-08

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