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 2018-06-26 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[112852205] The investigation determined that lower than expected vitros vanc results were obtained from two different non-vitros, biorad quality control fluids when processed on a vitros 5600 integrated system. The definitive assignable cause for this event could not be determined. An issue isolated to the two reagent packs is likely to be a contributing factor. It is possible these reagent packs were contaminated, although, this cannot be confirmed. The qc fluid results indicate the reagent performance is within expectations when the two reagent packs are removed. Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with results less than the measuring range for vitros vanc reagent lot 2514-35-6400. Therefore, a systemic reagent issue can be ruled out as a contributing factor. In order to verify the instrument performance, within run marker precision testing was requested, but not provided. Although there is no evidence the instrument is not performing within expectations, the instrument cannot be ruled out as a contributing factor. The assignable cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10


[112852206] A customer observed lower than expected vitros vancomycin (vanc) quality control results from two different non-vitros biorad quality control fluids (lot 40950) obtained using a vitros vanc reagent lot 2514-35-6400 when tested on a vitros 5600 integrated system. Biorad liquicheck immunoassay plus control level 2 (lot 40952) vitros vanc results <5, <5, and <5 ug/ml vs. Expected result of 17. 1 ug/ml. Biorad liquicheck immunoassay plus control level 3 (lot 40953) vitros vanc results <5, <5, <5 and <5 ug/ml vs. Expected result of 31. 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. There were no patient results reported outside of the laboratory and there was no allegation of actual patient harm as a result of this event. 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. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319808-2018-00018
MDR Report Key7637487
Date Received2018-06-26
Date of Report2018-06-26
Date of Event2018-05-26
Date Mfgr Received2018-05-31
Device Manufacturer Date2017-09-27
Date Added to Maude2018-06-26
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 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 Received2018-06-26
Catalog Number6801709
Lot Number2514-35-6400
ID Number10758750006731
Device Expiration Date2018-08-27
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 2018-06-26

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