VITROS CLINICAL CHEMISTRY PRODUCTS AMON SLIDES 1721869

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-26 for VITROS CLINICAL CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[44472548] The investigation determined higher than expected vitros amon results were obtained from vitros quality control fluids using the vitros amon slides on a vitros 5600 integrated system. An assignable cause was not determined. However, an amon reagent issue, an instrument issue, or a fluid handling issue cannot be ruled out as contributing factors.
Patient Sequence No: 1, Text Type: N, H10


[44472549] Higher than expected ammonia results were obtained from two levels of vitros quality control fluids when using vitros ammonia (amon) slides on a vitros 5600 integrated system. Vitros lpvi vitros amon results 103. 3, 170. 2, 158. 7, and 166. 2 umol/l versus expected 45 umol/l; vitros lpvii vitros amon results 237, 310, 293, and 296 umol/l versus expected 176. 9 umol/l. Patient samples were not processed due to the higher than expected control results. However the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number three of eight mdr's for this event. Eight 3500a forms are being submitted for this event as eight 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 Number1319809-2016-00037
MDR Report Key5608970
Date Received2016-04-26
Date of Report2016-04-26
Date of Event2016-03-19
Date Mfgr Received2016-03-29
Device Manufacturer Date2015-07-17
Date Added to Maude2016-04-26
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 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 CLINICAL CHEMISTRY PRODUCTS AMON SLIDES
Generic NameIN-VITRO DIAGNOSTIC
Product CodeJID
Date Received2016-04-26
Catalog Number1721869
Lot Number1015-0240-5383
Device Expiration Date2017-01-01
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 2016-04-26

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