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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT IN-VITRO DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 1896836
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that non-reproducible, higher than expected vitros ckmb results were obtained from a quality control fluid processed on the vitros eci immunodiagnostic system. The investigation could not determine a definitive assignable cause with the information provided. Results from precision testing of the customer¿s vitros eci immunodiagnostic system prior to and following service actions by an ortho field engineer indicate that the instrument was operating as expected. There was no indication that an instrument performance issue contributed to the event. Historical qc data shows no evidence of a reagent performance issue, however, since quality control fluid was affected, an unexpected reagent related issue cannot be entirely ruled out as contributing to the event. Finally, inappropriate pre-analytical sample handling could not be entirely ruled out as contributing to the higher than expected ckmb results as sufficient information was not provided to determine whether the customer was following an appropriate fluid handling protocol. A definitive assignable cause for the event could not be determined.
 
Event Description
The customer obtained non-reproducible, higher than expected vitros ckmb results from quality control fluid tested on a vitros eci immunodiagnostic system. Level 1 qc: 8. 45, 6. 95, 7. 12, 5. 69, 6. 96, 6. 48 and 6. 52 ng/ml versus expected result of 3. 27 ng/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The non-reproducible, higher than expected vitros ckmb quality control fluid results were not reported outside of the laboratory. No evidence was provided by the customer to suggest that patient results were affected, however the investigation cannot conclude that patient results would not to be affected if the event were to recur undetected. There is no allegation of actual patient harm as a result of this event. (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT
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 Key5811269
MDR Text Key50919704
Report Number3007111389-2016-00126
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 07/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/12/2016
Device Catalogue Number1896836
Device Lot Number1900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2015
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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