VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES 1314343

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 2008-10-08 for VITROS CHEMISTRY PRODUCTS SALICYLATE SLIDES 1314343 manufactured by Ortho-clinical Diagnostics, Inc..

Event Text Entries

[971073] A customer observed negatively biased proficiency results using vitros sali slides on a vitros 5,1 fs chemistry system. Biased results of the direction and magnitude observed on a pt specimen may lead to inappropriate physician action. No pt results were affected and there were no allegations of pt harm as a result of this event. Note: this form 3500a is two of five mdrs for this event. Five devices were involved. Five proficiency samples were assayed using a single sali slide lot. This report corresponds to ortho clinical diagnostics inc. (b) (4).
Patient Sequence No: 1, Text Type: D, B5


[8215271] The investigation determined that the negatively biased sali proficiency results were isolated to the last five slides in one vitros sali slide cart. The root cause could not be determined but may be related to user error when handling the sali slide cart in question. A new slide from the same sali slide lot and from an alternate sali slide lot produced acceptable proficiency results.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319809-2008-00301
MDR Report Key1202457
Report Source05
Date Received2008-10-08
Date of Report2008-09-12
Date of Event2008-09-11
Date Mfgr Received2008-09-12
Device Manufacturer Date2008-02-01
Date Added to Maude2010-04-19
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 ContactJOE FALVO
Manufacturer Street100 INDIGO CREEK BLVD.
Manufacturer CityROCHESTER NY 146265101
Manufacturer CountryUS
Manufacturer Postal146265101
Manufacturer Phone5854535735
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 SALICYLATE SLIDES
Generic NameIN-VITRO DIAGNOSTIC
Product CodeDKJ
Date Received2008-10-08
Model NumberNA
Catalog Number1314343
Lot Number2229-0052-6491
ID NumberNA
Device Expiration Date2009-02-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626510 US 14626 5101


Patients

Patient NumberTreatmentOutcomeDate
10 2008-10-08

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