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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 DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 1896836
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2015
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected ck-mb result was obtained from a single patient sample using vitros ck-mb reagent with a vitros eci immunodiagnostic system. The definitive assignable cause could not be determined. An instrument issue could not be ruled out as contributing to the event as an assessment of the system has yet to be performed. Historical quality control data was not provided and therefore a vitros ck-mb lot 1850 performance issue could also not be ruled out as a contributing factor. Ortho determined that the customer was not following the sample collection device manufacturer¿s recommendations for sample centrifugation, so pre-analytical sample handling could not be ruled out as contributing to the event. It is likely that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
 
Event Description
A customer obtained a non-reproducible, higher than expected creatine kinase-mb (ck-mb) result from a single patient sample (ck-mb
=
3. 32 ng/ml vs. Expected result of 2. 04 ng/ml) using vitros ck-mb reagent with a vitros eci immunodiagnostic system. 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 ck-mb result was reported from the laboratory, however, there was no allegation of patient harm as a result of the event. (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Type of DeviceIN-VITRO DIAGNOSTIC
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 Key5379349
MDR Text Key36955856
Report Number3007111389-2016-00008
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 01/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/06/2016
Device Catalogue Number1896836
Device Lot Number1850
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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