VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for VITROS CHEMISTRY PRODUCTS VANC REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[139320477] The investigation confirmed that lower than expected vitros vanc (vancomycin) and vitros valp (valproic acid) results were obtained from two patient samples and on two levels of non-vitros (biorad) quality control (qc) fluids on a vitros 4600 chemistry system. The investigation was able to determine the assignable cause for the lower than expected vitros vanc and valp results were the reagent packs in use at the time of the event. The lower than expected results were obtained from a single pack of vitros vanc reagent and a single pack of vitros valp reagent. Expected results were obtained after a new, unused pack of vitros vanc and a new, unused pack of vitros valp were placed on the instrument. Although proper reagent handling for both vitros vanc and vitros valp was verified, improper pack handling cannot be ruled out as a possible cause of this event. The assignable cause of what affected the reagent packs in use at the time of the events could not be determined. A diagnostic within run vitros gent (gentamicin) precision test was within ortho guidelines both pre and post service indicating the vitros 4600 chemistry system was performing as expected. An instrument related issue can be ruled out as a contributing factor to the event. Historical qc results indicate that vitros vanc lot 2514-37-6935 and vitros valp lot 2511-26-6892 are performing as intended. A transient issue related to the reagent performance cannot be ruled out as a contributing factor. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros vanc lot 2514 37 6935 or vitros valp lot 2511 26 6892.
Patient Sequence No: 1, Text Type: N, H10


[139320478] A customer obtained lower than expected vitros vanc (vancomycin) and vitros valp (valproic acid) results from two patient samples and on two levels of non-vitros (biorad) quality control (qc) fluids on a vitros 4600 chemistry system. Patient 1 vitros vanc result <5 ug/ml vs. Expected result of 20. 7 ug/ml. Patient 2 vitros vanc result <5 ug/ml vs. Expected result of 17. 58 ug/ml. Liquicheck immunoassay plus control level 3 (lot 40973) vitros vanc results 9. 0, 8. 6 and 9. 2 ug/ml vs. Expected result of 28. 03 ug/ml. Liquicheck immunoassay plus control level 1 (lot 40971) vitros valp results <10, <10 and <10 ug/ml vs. Expected result of 35. 9 ug/ml. Liquicheck immunoassay plus control level 3 (lot 40973) vitros valp results 51. 5, 53. 0 and 51. 8 ug/ml vs. Expected result of 121. 4 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The lower than expected patient results were reported from the laboratory, but corrected reports were sent. There were no reports of changes in treatment based on the lower than expected patient results. There was no allegation of actual patient harm as a result of this event. This report is number one of two mdr? S for this event. Two 3500a forms are being submitted for this event as a total of two devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319808-2019-00007
MDR Report Key8408060
Date Received2019-03-11
Date of Report2019-03-11
Date of Event2019-02-12
Date Mfgr Received2019-02-13
Device Manufacturer Date2018-06-22
Date Added to Maude2019-03-11
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 Street1000 LEE ROAD
Manufacturer CityROCHESTER NY 14606
Manufacturer CountryUS
Manufacturer Postal Code14606
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVITROS CHEMISTRY PRODUCTS VANC REAGENT
Generic NameIN-VITRO DIAGNOSTIC
Product CodeLEH
Date Received2019-03-11
Catalog Number6801709
Lot Number2514-37-6935
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 2019-03-11

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