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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 6 IN VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 6 IN VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1204247
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that lower than expected vitros ckmb results were obtained from vitros isoenzyme performance verifier (pv) quality control fluids processed on a vitros 350 chemistry system. The assignable cause of the event was an issue with the calibration parameters in use and was resolved by recalibration of the vitros ckmb slide lot using an alternate calibrator kit lot number. The tsc did not obtain any details regarding pre-analytical calibrator reconstitution and handling. However, it was noted that the calibrator fluids were 7 days old at the time of the second calibration event. Per the calibrator kit 6 instructions for use, the fluids are only stable for up to 24 hours refrigerated. Therefore, an issue with the calibrator fluids was a likely contributing factor to the event. In addition, an issue with the quality controls fluids could not be definitively ruled out as it was not known if the customer tried a fresh preparation of quality control fluids. It is unknown if the customer loaded a new slide cartridge for troubleshooting purposes and a transient vitros ckmb slide issue could not be ruled out as a potential contributing factor. However, ongoing tracking and trending of complaints has not identified any signals that would point to a systemic issue with vitros ckmb lot 4948-0234-5966. There was no indication of an instrument malfunction and unexpected instrument performance was not a likely contributor to the event.
 
Event Description
A customer contacted the ortho clinical diagnostics (ortho) technical service center (tsc) to report lower than expected vitros chemistry products ckmb slides results were obtained from quality control fluids processed on a vitros 350 chemistry system. Vitros pv d7182
=
14, 15, 15 versus expected 21 u/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The customer indicated this vitros ckmb slide lot had not been placed into routine use because the qc results were unacceptable. There were no allegations of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 6
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
1000 lee road
rochester NY 14606
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key10583042
MDR Text Key209155199
Report Number1319808-2020-00038
Device Sequence Number1
Product Code JHS
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 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2021
Device Catalogue Number1204247
Device Lot Number0679
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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