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 2017-01-17 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[65361612] The investigation determined that lower than expected vitros dgxn results were obtained from a vitros quality control fluid in combination with a vitros 5600 integrated system. A definitive assignable cause could not be determined. An instrument related issue cannot be ruled out as a possible cause of the lower than expected vitros dgxn results. Historical dgxn quality control results indicate unacceptable within lab precision; however the immuno rate metering tubing was replaced on the vitros 5600 system prior to performing a within run vitros dgxn precision. Therefore a vitros 5600 system issue could not be confirmed as the cause of the lower than expected dgxn results. Vitros dgxn lot 1911-0240-5046 is no longer available for additional testing, therefore a reagent issue could not be ruled out as a contributor to the lower than expected dgxn results observed. The assignable cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10


[65361613] A customer observed lower than expected vitros dgxn quality control results obtained from a vitros quality control fluid when using a vitros 5600 integrated system. Vitros dgxn results 1. 60, 1. 35, 1. 33 and 1. 13 ng/ml versus expected dgxn result 2. 13 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. Ortho clinical diagnostics (ortho) has not been made aware of any erroneous vitros dgxn patient sample results obtained or reported from the laboratory during the time frame of this event, however, the investigation could not rule out that patient samples were not, or would not be affected if the event were to recur undetected. There was no allegation of actual patient harm as a result of this event. This report is number one of four mdr? S for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319809-2017-00010
MDR Report Key6255267
Date Received2017-01-17
Date of Report2017-01-17
Date of Event2016-12-20
Date Mfgr Received2016-12-23
Device Manufacturer Date2016-09-01
Date Added to Maude2017-01-17
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 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 Received2017-01-17
Catalog Number8343386
Lot Number1911-0240-5046
Device Expiration Date2017-02-01
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 2017-01-17

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