VITROS MALB REAGENT 6801740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2010-07-16 for VITROS MALB REAGENT 6801740 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[1594634] This customer obtained lower than expected vitros malb results for three patient samples while using the vitros 5,1 fs chemistry system. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The original results were reported to the clinician. There were no allegations of harm to the patients as a result of these events. This report is number three of three mdrs for this event. Three 3500a forms are being submitted for this event as three devices (three reported false negative results from the customer) were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[8563819] The investigation confirmed that lower than expected vitros malb patient results were obtained while using the vitros 5,1 fs analyzer. A definitive root cause has not be determined. However, an antigen excess effect in the presence of elevated albumin levels in the patient samples cannot be ruled out. The investigation into vitros malb reagent performance is ongoing.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319808-2010-00014
MDR Report Key1759974
Report Source00,01,05
Date Received2010-07-16
Date of Report2010-07-16
Date of Event2010-01-28
Date Mfgr Received2010-06-18
Device Manufacturer Date2009-11-13
Date Added to Maude2011-04-15
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 FDA0
Event Location0
Manufacturer ContactMR. JOSEPH FALVO
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 Report3

Device Details

Brand NameVITROS MALB REAGENT
Generic NameIN VITRO DIAGNOSTIC
Product CodeJZJ
Date Received2010-07-16
Catalog Number6801740
Lot Number1505-04-9484
Device Expiration Date2011-03-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2010-07-16

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