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 from a foreign,health professional,o report with the FDA on 2018-12-11 for VITROS CHEMISTRY PRODUCTS DGXN SLIDES 8343386 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[130658669] The investigation concluded that lower than expected vitros chemistry products dgxn results were attained from non-vitros quality control (qc) fluids using vitros dgxn slides in combination with a vitros 5,1 fs chemistry system. An assignable cause for the event could not be determined. After the customer performed a secondary calibration event using vitros dgxn lot 1916-0251-2567 on (b)(6) 2018, the qc results were acceptable. Although it is unknown if the customer performed maintenance activities, the precision after this calibration event improved suggesting possible action by the customer prior to the calibration event may have mitigated a possible unknown analyzer related issue. Therefore, an analyzer related issue cannot be ruled out nor confirmed as the cause of the event. Because the calibration parameters for both the original calibration event and (b)(6) 2018 calibration event were similar, a suboptimal calibration is not a likely cause of the lower than expected results. Furthermore, the improved performance using the same reagent indicates the vitros dgxn reagent lot 1916-0251-2567 did not contribute to the event. The continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros chemistry products dgxn slides lot 1916-0251-2567.
Patient Sequence No: 1, Text Type: N, H10


[130658670] A customer reported lower than expected vitros digoxin (dgxn) results from non-vitros quality control (qc) fluids processed using vitros chemistry products dgxn slides in combination with a vitros 5,1 fs chemistry system. Non-vitros qc fluid biorad level 2 vitros dgxn results of 1. 97, 1. 92, 1. 90, 1. 90, 1. 91, 1. 75, 1. 94, 1. 99, 1. 60, 1. 64, 1. 93, 1. 75, 1. 84 and 1. 67 mg/dl versus the expected vitros dgxn result of 3. 22 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected vitros dgxn results were obtained when processing quality control fluids. However, it cannot be concluded that patient sample results were not affected or would not be affected if the event were to recur undetected. There were no allegations of patient harm as a result of this event. This report is number 6 of 14 mdr? S for this event. Fourteen (14) 3500a forms are being submitted for this event as 14 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 Number1319809-2018-00156
MDR Report Key8150309
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2018-12-11
Date of Report2019-01-02
Date of Event2018-10-24
Date Mfgr Received2018-11-19
Device Manufacturer Date2018-08-25
Date Added to Maude2018-12-11
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 Report3

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS DGXN SLIDES
Generic NameIN VITRO DIAGNOSTICS
Product CodeLFM
Date Received2018-12-11
Catalog Number8343386
Lot Number1916-0251-2567
Device Expiration Date2019-01-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2018-12-11

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