VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2014-08-14 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[4774090] The customer obtained lower than expected vitros dgxn quality control results (mas level 3= 0. 48, <0. 4, 0. 47, <0. 4, <0. 4, <0. 4, 0. 53 vs. Expected 2. 0 ng/ml) processed on a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were known to have been affected or reported from the laboratory. There was no allegation of patient harm as a result of this event. This report is number five of seven mdr? S for this event. Seven 3500a forms are being submitted for this event as seven devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11949358] The investigation determined that lower than expected vitros dgxn quality control results were obtained on a vitros 5600 integrated chemistry system. There was no indication that an instrument issue contributed to the event. The investigation could not determine an assignable cause. A vitros dgxn reagent issue, improper pre-analytical fluid handling protocol or the mas control fluids in use cannot be ruled out as contributing factors to the event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319809-2014-00035
MDR Report Key4010226
Report Source00,01,05
Date Received2014-08-14
Date of Report2014-08-14
Date of Event2014-07-09
Date Mfgr Received2014-07-16
Device Manufacturer Date2014-02-27
Date Added to Maude2014-08-28
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 Street513 TECHNOLOGY BLVD.
Manufacturer CityROCHESTER NY 14652
Manufacturer CountryUS
Manufacturer Postal Code14652
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS DGXN SLIDES
Generic NameIN VITRO DIAGNOSTICS
Product CodeKXT
Date Received2014-08-14
Catalog Number8343386
Lot Number1904-0220-1743
Device Expiration Date2014-08-15
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 2014-08-14

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