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U.S. Department of Health and Human Services

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

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 6801042
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation concluded that multiple lower than expected myog quality control results were obtained using a single non-vitros quality control level in combination with a vitros 5600 integrated system. The investigation could not determine a definitive assignable cause. A within run vitros tt4 marker precision test, used to assess instrument function, was not performed, therefore the vitros 5600 system could not be entirely ruled out as a contributing factor. Based on historical quality control results, a vitros myog reagent performance issue is not a likely contributor to the event, however the possibility that an unexpected vitros myog reagent performance issue or a pre-analytical sample handling issue contributing to the results could not be entirely ruled out. A definitive assignable cause for the event could not be determined.
 
Event Description
The customer observed multiple lower than expected vitros myog results obtained from a single non-vitros biorad quality control fluid processed on a vitros 5600 integrated system. Biorad l5 control results of 110. 773, 107. 156, 116. 864, 114. 667, 113. 300, 115. 402, 115. 048, 109. 252, 111. 79, and 115. 014 ng/ml versus customer established baseline mean 127. 95 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples. Ortho has not been made aware of any erroneous vitros myog patient results obtained or reported from the laboratory over the time frame of the event, however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number one of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho). Complaint number (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS MYOG 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 Key5854541
MDR Text Key52735598
Report Number3007111389-2016-00140
Device Sequence Number1
Product Code DDR
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 08/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2016
Device Catalogue Number6801042
Device Lot Number1100
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 Received07/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2015
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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