VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-12 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[100263455] The investigation determined that lower than expected vitros dgxn results were obtained for performance verifier fluid results processed using vitros digoxin (dgxn) slides lot 1913-0247-5668 on a vitros 4600 chemistry system (s/n (b)(4)). The investigation was unable to determine an assignable cause. There is no indication that the instrument is the cause of the lower than expected results as quality control results were acceptable. A reagent issue cannot be ruled out as a contributing factor as elevated imprecision was observed across the measuring range and for multiple fluid types. However, all testing has shown performance of vitros dgxn slide lot 1913-0247-5668 is within claims, labeling and specifications.
Patient Sequence No: 1, Text Type: N, H10


[100263456] An ortho clinical diagnostics scientist reported lower than expected performance verifier fluid results processed using vitros digoxin (dgxn) slides on a vitros 4600 chemistry system. Performance verifier level 2 (lot m5007) results of 1. 492, 1. 466, 1. 671 nmol/l vs. An expected result of 2. 246 nmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No results were reported outside of the laboratory. There was no report of patient harm. (b)(4). This report is number 1 of 3 mdr? S for this event. Three (3) 3500a forms are being submitted for this event as 3 devices were involved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319809-2018-00015
MDR Report Key7262940
Date Received2018-02-12
Date of Report2018-02-12
Date of Event2017-12-05
Date Mfgr Received2018-01-15
Device Manufacturer Date2017-11-21
Date Added to Maude2018-02-12
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 DGXN SLIDES
Generic NameIN VITRO DIAGNOSTIC
Product CodeLFM
Date Received2018-02-12
Catalog Number8343386
Lot Number1913-0247-5668
ID Number10758750004782
Device Expiration Date2018-04-15
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 2018-02-12

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