VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for VITROS CHEMISTRY PRODUCTS GENT REAGENT 6801711 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[39470709] The investigation determined that lower than expected vitros gent and vanc quality control results were obtained from two different lots of vitros tdm pv3 controls on a vitros 5600 integrated system. The assignable cause of the event is unknown. An instrument issue cannot be ruled out. The customer performed maintenance on the instrument changing the photometer lamp, metering proboscis and recalibrated using fresh reagent packs. Following these maintenance actions, acceptable gent and vanc quality control results were observed. However, a pre-maintenance vitros within-run precision test was not performed; therefore, an instrument related issue cannot be ruled out. No direct evidence of a reagent issue could be confirmed or ruled out as a contributor to the event. Finally, improper pre-analytical sample handling of the vitros tdm pv fluids cannot be ruled out as a possible contributing factor. The assignable cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10


[39470710] A customer observed multiple lower than expected vitros vanc and vitros gent quality control results on two different lots of vitros tdm pv3 controls on a vitros 5600 integrated system. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected. No patient samples were processed during the timeframe the quality control results were unacceptable, however, the investigation could not confirm that patient samples 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 Number1319808-2016-00003
MDR Report Key5462716
Date Received2016-02-26
Date of Report2016-02-26
Date of Event2016-01-28
Date Mfgr Received2015-12-15
Device Manufacturer Date2015-07-01
Date Added to Maude2016-02-26
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 GENT REAGENT
Generic NameIN-VITRO DIAGNOSTIC
Product CodeLCD
Date Received2016-02-26
Catalog Number6801711
Lot Number1512-10-4719
Device Expiration Date2017-07-01
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 2016-02-26

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