VITROS 5600 INTEGRATED SYSTEM 6802413

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-23 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[90797450] The investigation determined lower than expected vitros dgxn quality control results were obtained from two different quality control fluids on a vitros 5600 integrated system. The most likely assignable cause is instrument related. Prior to service actions performed by an ortho fe the within-run dgxn precision test was outside of ortho guidelines indicating the vitros 5600 integrated system was not performing as intended. Acceptable within-run precision dgxn results were obtained after service actions which included the replacement of the immuno rate re-insert blade motor, immuno rate wash cam, reflectometer optics, and all associated adjustments. ; indicating an instrument related issue is the likely assignable cause of the event. The investigation found no evidence the vitros dgxn reagent malfunctioned. Acceptable performance was observed when processing the quality control fluids after the completion of service actions.
Patient Sequence No: 1, Text Type: N, H10


[90797451] A customer observed lower than expected vitros dgxn quality control results obtained from a non-vitros biorad control and a vitros tdm performance verifier iii control fluid on a vitros 5600 integrated system. Biorad liquichek immunoassay plus control, lot 47903 vitros dgxn result 1. 98 ng/ml versus biorad peer group mean 2. 69 ng/ml. Vitros tdm performance verifier iii lot h5125 result 1. 88 ng/ml versus the midpoint of the range of means (rom) 2. 8 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Patient samples were not tested for vitros dgxn while quality control results were outside of expected ranges, however, the investigation could not rule out that patient samples would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319681-2017-00093
MDR Report Key6968366
Date Received2017-10-23
Date of Report2017-10-23
Date of Event2017-09-28
Date Mfgr Received2017-09-28
Device Manufacturer Date2011-03-15
Date Added to Maude2017-10-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
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 Report0

Device Details

Brand NameVITROS 5600 INTEGRATED SYSTEM
Generic NameCHEMISTRY ANALYZER
Product CodeKXT
Date Received2017-10-23
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 2017-10-23

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