VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[40121998] The assignable cause of the event is a known limitation of the vitros ckmb slide assay. The results of the non-vitros fractionation indicate that 34% of the total ck enzyme in the sample consists of the macro type i isoenzyme. Per the vitros ckmb slide assay instruction for use (ifu), macro ck type i and type ii can cause falsely elevated vitros ckmb results. There was no indication the vitros ckmb microslide reagent or the vitros 5600 instrument malfunctioned.
Patient Sequence No: 1, Text Type: N, H10


[40121999] The customer reported higher than expected vitros ckmb results were obtained from a single patient sample using two different lots of vitros ckmb slides on a vitros 5600 analyzer, when compared to a non-vitros fractionation method. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Vitros ckmb slide lot 4935-0202-5258. Patient sample result of 104 u/l vs. The expected result of <16 u/l. Vitros ckmb slide lot 4935-0202-6522. Patient sample result of 104 u/l vs. The expected result of <16 u/l. The higher than expected results were not reported outside of the laboratory. There was no report of patient harm as a result of this event. This report is number 2 of 2 mdr's for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319809-2016-00033
MDR Report Key5484451
Date Received2016-03-07
Date of Report2016-03-07
Date of Event2016-01-21
Date Mfgr Received2016-02-12
Device Manufacturer Date2015-08-31
Date Added to Maude2016-03-07
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 CKMB SLIDES
Generic NameIN-VITRO DIAGNOSTIC
Product CodeJHX
Date Received2016-03-07
Catalog Number8001133
Lot Number4935-0202-6522
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 2016-03-07

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