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 with the FDA on 2018-10-24 for VITROS CHEMISTRY PRODUCTS AMON SLIDES 1721869 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[126383753] The investigation concluded that higher than expected vitros clinical chemistry products ammonia (amon) results were obtained from cap general chemistry quality cross check samples using vitros amon slides lot 1018-0249-9308 on a vitros 5600 integrated system. The investigation could not confirm the assignable cause of the event. The quality control results were within 1 to 2 sd of the biorad peer group mean after the initial calibration as well as on the day the cap fluids were processed. Additionally, the within run vitros amon precision test was within ortho guidelines indicating the vitros 5600 is performing as expected. There is no evidence to suggest vitros amon slides lot 1018-0249-9308 or the vitros 5600 system are not performing as expected. Furthermore, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros amon slides lot 1018-0249-9308. Additional information regarding the handling of the cap fluids was not provided. An issue with the samples is the suspected cause of the event, however, a fluid handling issue or an issue related to the samples could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10


[126383754] A customer reported higher than expected vitros clinical chemistry products ammonia (amon) results obtained from college of american pathologists (cap) general chemistry quality cross check samples using vitros amon slides lot 1018-0249-9308 on a vitros 5600 integrated system. Czq-a 02 vitros amon result 709 umol/l versus expected vitros amon result 574. 8 umol/l; czq-a 03 vitros amon result 444 umol/l versus expected vitros amon result 369. 2 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected vitros amon results were obtained when processing cap fluids. There were no allegations of patient harm as a result of this event. This report is number 1 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 Number1319809-2018-00114
MDR Report Key7998935
Date Received2018-10-24
Date of Report2018-10-24
Date of Event2018-09-28
Date Mfgr Received2018-10-02
Device Manufacturer Date2018-04-22
Date Added to Maude2018-10-24
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 AMON SLIDES
Generic NameIN VITRO DIAGNOSTICS
Product CodeJID
Date Received2018-10-24
Catalog Number1721869
Lot Number1018-0249-9308
Device Expiration Date2019-10-01
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 2018-10-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.