VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-13 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[100271528] The investigation determined that higher and lower than expected vitros vanc results were obtained from vitros control fluids and non-vitros control fluids processed on a vitros 5600 integrated system. The assignable cause of the lower than expected vitros vanc results is a reagent pack related issue. The affected results were isolated to a single reagent pack. The issue with the affected reagent pack is unknown, as the pack was discarded by the customer and no further investigation was possible. The assignable cause of the higher than expected vitros vanc results is improper fluid handling as the control fluids were improperly stored at room temperature. Acceptable quality control results were obtained when using fresh controls. There is no evidence to suggest the vitros 5600 system malfunctioned. With the exception of the affected reagent pack, based on historical quality control results there was no indication that vitros vanc reagent lot 2514-36-6074 was not performing as intended.
Patient Sequence No: 1, Text Type: N, H10


[100271529] A customer obtained higher and lower than expected vitros vanc results from vitros quality controls and non-vitros quality control fluids using vitros vanc reagent on a vitros 5600 integrated system. Biorad level 1 lot 40951 vitros vanc result 16. 27 ug/ml versus expected vanc result 15. 90 ug/ml. Biorad level 2 control lot 40952 vitros vanc result < 5. 0 and <5. 0 ug/ml versus expected vanc result 15. 90 ug/ml. Vitros tdm pvi lot v6155 vitros vanc result 19. 30 ug/ml versus the midpoint of the vitros tdm pvi range of means 7. 50 ug/ml. Vitros tdm pvii lot t5896 vitros vanc result <5. 0 ug/ml versus the midpoint of the vitros tdm pvii range of means 39. 8 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher and lower than expected vitros vanc results were obtained when processing quality control fluids on the vitros 5600 system. Ortho was not made aware of any allegation of patient harm as a result of this event. However the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. This report is number one of two mdr's for this event. Two 3500a forms are being submitted for this event as two devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319808-2018-00008
MDR Report Key7266664
Date Received2018-02-13
Date of Report2018-02-13
Date of Event2018-01-16
Date Mfgr Received2018-01-16
Device Manufacturer Date2017-07-25
Date Added to Maude2018-02-13
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 Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO-CLINICAL DIAGNOSTICS
Manufacturer Street1000 LEE ROAD
Manufacturer CityROCHESTER NY 14606
Manufacturer CountryUS
Manufacturer Postal Code14606
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS VANC REAGENT
Generic NameIN VITRO DIAGNOSTIC
Product CodeLEH
Date Received2018-02-13
Catalog Number6801709
Lot Number2514-36-6074
ID Number10758750006731
Device Expiration Date2018-05-05
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 2018-02-13

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