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U.S. Department of Health and Human Services

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

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 1912997
Device Problem High Test Results (2457)
Patient Problem No Patient Involvement (2645)
Event Date 04/08/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation determined lower than expected vitros tsh results were obtained from 3 patient samples processed on a vitros 5600 integrated system. The investigation was unable to determine an assignable cause. Based on acceptable historical qc review and within-run precision test results, the investigation found no evidence to suggest that a vitros reagent or instrument malfunction contributed to the event.
 
Event Description
The customer obtained lower than expected vitros tsh results on 3 patient samples tested on a vitros 5600 integrated system. Patient b vitros tsh result of 0. 267 miu/l versus non-vitros 0. 440 miu/l. Patient c vitros tsh result of 0. 191 miu/l versus non-vitros 0. 350 miu/l. Patient d vitros tsh result of 0. 237 miu/l versus non-vitros 0. 430 miu/l. Biased results of the direction and magnitude observed could lead to inappropriate physician action. The erroneous patient sample results were reported from the laboratory, however, a physician questioned the results and retested the samples before any action was taken. There was no allegation of patient harm as a result of this event. This report is number two of three 3500a forms filed for this event, as three devices were affected. (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS TSH 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 Key5726809
MDR Text Key48422440
Report Number3007111389-2016-00103
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeKS
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 06/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/25/2016
Device Catalogue Number1912997
Device Lot Number5030
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 Received05/17/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2015
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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