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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1896836
Device Problem High Readings (2459)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that a higher than expected vitros ck-mb result was attained from a vitros cliniqa quality control (qc) fluid processed using vitros immunodiagnostics products ck-mb reagent lot 2640 in combination with a vitros xt 7600 integrated system. A definitive assignable cause could not be determined. An issue related to the initial calibration of reagent lot 2640 cannot be ruled out nor confirmed as a contributing factor of the event as there were no remaining calibrator fluids for lot 2640 left to continue troubleshooting with. Instead, a new calibration event was performed using an alternate reagent lot. Continual tracking and trending of complaint data does not indicate a potential systemic issue with vitros ck-mb lot 2640. Cliniqa controls were not processed following the calibration using the new lot and therefore, an issue with the cliniqa controls cannot be ruled out as a potential cause of the event. Although a within run precision test was not performed, an issue with the vitros xt 7600 integrated system is not a likely contributor of the event as a new calibration with a new lot of reagent resolved the issue.
 
Event Description
A customer reported a higher than expected vitros ck-mb result obtained from a vitros cliniqa quality control (qc) fluid when processed using vitros immunodiagnostics products ck-mb reagent in combination with a vitros xt 7600 integrated system. Cliniqa liquid cardiac marker level 1 lot 190701 vitros ck-mb result of 6. 21 ng/ml versus an expected result of 3. 00 ng/ml. 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 ck-mb result was obtained when processing a quality control fluid during an analyzer installation. Patient samples were not yet being processed on this analyzer and there was no allegation of patient harm as a result of this event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. This report corresponds to ortho clinical diagnostics inc. (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO CLINICAL DIAGNOSTICS
felindre meadows
pencoed
bridgend, wales CF35 5PZ
UK CF35 5PZ
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key9791374
MDR Text Key224677052
Report Number3007111389-2020-00023
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2020
Device Catalogue Number1896836
Device Lot Number2640
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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