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 with the FDA on 2017-03-15 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[70330597] The investigation determined that lower than expected vitros dgxn patient results were obtained on a vitros 5600 integrated system. The assignable cause for the event is unknown. An issue with vitros dgxn reagent lot 1911-0240-6317 or the vitros 5600 system cannot be completely ruled out as contributing factors to the event. In addition, improper pre-analytical sample processing (centrifugation) is a possible contributing factor to the event. The customer is not centrifuging the samples in accordance with the sample collection device manufacturer's recommendations and improper pre-analytical sample handling cannot be ruled out as contributing to the event. It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed. No information was provided regarding the patient? S medication, therefore, a possible interferent cannot be ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10


[70330598] A customer observed lower than expected vitros dgxn results from 2 samples from the same patient obtained on a vitros 5600 integrated system. Patient sample 1 result of 1. 9 ng/ml vs. The expected result of 2. 65 ng/ml. Patient sample 2 result of 1. 4 ng/ml vs. The expected result of 2. 04 ng/ml. This report is number two of two mdr? S for this event. Two 3500a forms are being submitted for this event as two devices were involved. The lower than expected results were not reported outside of the laboratory, and there were no allegations of patient harm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319809-2017-00021
MDR Report Key6408198
Date Received2017-03-15
Date of Report2017-03-15
Date of Event2017-01-26
Date Mfgr Received2017-02-15
Device Manufacturer Date2016-10-25
Date Added to Maude2017-03-15
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 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 Street513 TECHNOLOGY BLVD.
Manufacturer CityROCHESTER NY 14652
Manufacturer CountryUS
Manufacturer Postal Code14652
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS DGXN SLIDES
Generic NameIN VITRO DIAGNOSTIC
Product CodeLFM
Date Received2017-03-15
Catalog Number8343386
Lot Number1911-0240-6317
ID Number10758750004782
Device Expiration Date2017-03-15
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 2017-03-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.