VITROS CHEMISTRY PRODUCTS AMON SLIDES 1721869

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-12 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[5798044] The customer complained that lower and higher than expected vitros amon results were obtained from two different levels of non-vitros biorad controls and a single level of vitros lpv fluid tested on a vitros 350 chemistry system. Biorad l2 results: 126. 1, 82. 2, 64. 5, 80. 2, 79. 9, 82. 8, 68. 2, 49. 8, 79. 4, 52. 7, 59. 0, 79. 9, 57. 1, 51. 9, 71. 1, 70. 6, 73. 6, 64. 7, 77. 9, and 126. 4 umol/l vs expected result 104. 5 umol/l biorad l3 results: 196. 4, 197. 7, and 203. 4 umol/l vs expected result 262. 6 umol/l. Vitros lpv l3179 result: 235 umol/l compared to an expected result of 189. 2 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. No vitros amon patient sample results were questioned during the timeframe of the events; however, the investigation cannot conclude that patient sample results were not or could not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of these events. This report is number three of twenty-four mdr? S for this event. Twenty-four 3500a forms are being submitted for this event as twenty-four devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[13357333] The investigation determined that lower and higher than expected vitros amon results were obtained from two different levels of non-vitros biorad controls and a single level of vitros lpv fluid tested on a vitros 350 chemistry system. The assignable cause of the events is unknown; however, an unknown issue related to the vitros amon slides or improper pre-analytical fluid handling protocol cannot be ruled out as contributing to the events. The investigation found no indication the vitros 350 chemistry system malfunctioned. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319809-2015-00046
MDR Report Key4766051
Report Source05
Date Received2015-05-12
Date of Report2015-05-12
Date of Event2015-04-01
Date Mfgr Received2015-04-17
Device Manufacturer Date2014-05-12
Date Added to Maude2015-06-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
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 Report3

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS AMON SLIDES
Generic NameIN-VITRO DIAGNOSTIC
Product CodeJID
Date Received2015-05-12
Catalog Number1721869
Lot Number1014-0234-3725
Device Expiration Date2015-08-01
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 2015-05-12

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