VITROS 5600 INTEGRATED SYSTEM 6802413

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-23 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[83688594] The investigation determined that a lower than expected vitros dgxn result was obtained from a single level of non-vitros (biorad) quality control fluid using vitros dgxn slide lot 1913-0242-9253, tested on a vitros 5600 integrated system s/n (b)(4). The most likely assignable cause of the lower than expected vitros dgxn quality control result is an instrument performance issue, as a within-run vitros dgxn precision test was outside performance guidelines, indicating that the vitros 5600 integrated system was not performing as intended. Following service actions which included replacement of the immuno-wash fluid (iwf) metering assembly and iwf metering pump, acceptable vitros dgxn precision results were obtained, indicating service actions had returned the vitros 5600 system to expected performance. There is no evidence that vitros dgxn slide lot 1913-0242-9253 was not performing as expected. Acceptable performance was observed when processing the quality control fluids after the completion of service actions.
Patient Sequence No: 1, Text Type: N, H10


[83688595] A customer obtained a lower than expected vitros digoxin (dgxn) quality control result from a non-vitros quality control (qc) fluid, when compared to the customers established mean. The result was generated using vitros chemistry products dgxn slides processed on a vitros 5600 integrated system. Biorad liquichek immunoassay plus control, lot 40923 vitros dgxn result 1. 89 ng/ml versus dgxn expected result 3. 3 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer made no allegations that patient sample results were affected. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319681-2017-00067
MDR Report Key6813370
Date Received2017-08-23
Date of Report2017-08-23
Date of Event2017-08-25
Date Mfgr Received2017-08-01
Device Manufacturer Date2015-03-28
Date Added to Maude2017-08-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal Code14626
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameVITROS 5600 INTEGRATED SYSTEM
Generic NameCHEMISTRY ANALYZER
Product CodeKXT
Date Received2017-08-23
Catalog Number6802413
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626

Device Sequence Number: 1

Brand NameVITROS 5600 INTEGRATED SYSTEM
Generic NameCHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-08-23
Catalog Number6802413
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 2017-08-23

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