VITROS 5600 INTEGRATED SYSTEM 6802413

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 2015-02-10 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[20459549] A customer observed a lower than expected dgxn quality control result from a bio-rad qc fluid when using vitros chemistry products dgxn slides on a vitros 5600 integrated system. Bio-rad l3= 0. 63 vs. Expected 2. 75 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action. No patient samples were processed while the dgxn quality control results were outside of expected ranges; however, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[20564223] The investigation confirmed that a lower than expected dgxn quality control result was obtained from a bio-rad qc fluid when using vitros chemistry products dgxn slides on a vitros 5600 integrated system. The most likely root cause of this event is analyzer related. There was no indication the vitros dgxn reagent contributed to the event. Following service actions, acceptable qc results have been maintained indicating that service actions have resolved the issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319681-2015-00014
MDR Report Key4502421
Report Source05
Date Received2015-02-10
Date of Report2015-02-10
Date of Event2015-01-13
Date Mfgr Received2015-01-13
Device Manufacturer Date2012-07-19
Date Added to Maude2015-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
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 Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal Code14626
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITROS 5600 INTEGRATED SYSTEM
Generic NameCHEMISTRY ANALYZER
Product CodeKXT
Date Received2015-02-10
Catalog Number6802413
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-10

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