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 2012-07-12 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[2816252] A customer observed lower than expected vitros gent quality control results on a vitros 5600 integrated system. Values of 5. 44, 3. 83, 4. 70, and 4. 41 ug/ml were obtained from the biorad level 2 fluid versus the expected value or 7. 83 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were run for vitros gent during the time frame of this event. There was no report 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[10070566] The investigation determined that lower than expected vitros gent quality control results were obtained on a vitros 5600 integrated system. The customer depleted their inventory of vitros gent lot 1512-07-1075, therefore no additional performance tests were completed using the affected reagent lot. Ocd has received no related customer complaints for vitros gent lot 1512-07-1075 to suggest a reagent issue. An alternate lot of vitros gent reagent generated acceptable quality control performance. The investigation was unable to determine a definitive root cause. However, the vitros gent reagent could not be ruled out as a potential contributing factor. The investigation found no evidence to suggest that an issue with the vitros 5600 integrated system contributed to this event. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319808-2012-00019
MDR Report Key2653828
Report Source05
Date Received2012-07-12
Date of Report2012-07-12
Date of Event2012-05-31
Date Mfgr Received2012-06-13
Device Manufacturer Date2010-10-25
Date Added to Maude2012-10-26
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. 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 Received2012-07-12
Catalog Number6801711
Lot Number1512-07-1075
Device Expiration Date2012-08-31
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 2012-07-12

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