• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO VISION ID-MTS; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHO CLINICAL DIAGNOSTICS ORTHO VISION ID-MTS; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM Back to Search Results
Catalog Number 6904577
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2016
Event Type  malfunction  
Manufacturer Narrative
Discrepant abo grouping results for two donors¿ samples.The root-cause for the discrepant abo grouping results could not be determined.No general product failure is identified.No biased result was reported to the physicians.No patient was harmed.(b)(4).
 
Event Description
The customer reported that they had obtained discrepant abo grouping results for two donors¿ samples using biovue technique with their ortho vision biovue analyzer.Complainant name: mrs.(b)(6)¿ laboratory supervisor.Event date: (b)(6) 2016.Reported on: 27 october 2016 by mrs.(b)(6) to the helpdesk, who wrongly assessed the event.Ortho complaint handling unit was made aware on 23 march 2017.(missphs assigned on the same day).Software version: not provided.Reagents: ortho biovue system abo-rh/reverse grouping cassette lot abr152a exp.(b)(6) 2016.Ortho biovue system poly cassette lot ahc584a exp.(b)(6) 2017.Patient information: no information was provided.Donor information: donor (b)(6): known to be a(abo1), d(rh1) antigen positive; donor (b)(6): known to be b(abo2), d(rh1) antigen positive.The customer said that, on (b)(6) 2017, they had tested two patients for major crossmatch test against the two above mentioned donor samples using ortho biovue system poly cassette in conjunction with their ortho vision biovue analyzer and that they had obtained negative/compatible results.The customer said that, on the same day, they had tested the two above mentioned donor samples for abo grouping using ortho biovue system abo-rh/reverse grouping cassette in conjunction with their ortho vision biovue analyzer and that they had obtained : - b(abo2), d(rh1) antigen positive result for the donor being a(abo1), d(rh1) antigen positive - a(abo1), d(rh1) antigen positive result for the donor being b(abo2), d(rh1) antigen positive.The customer said that no biased result were reported to the physicians.The customer said that no patient was harmed as a consequence of these events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORTHO VISION ID-MTS
Type of Device
AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
Manufacturer (Section D)
ORTHO CLINICAL DIAGNOSTICS
1001 route 202
raritan NJ 08869
Manufacturer Contact
marta carnielli
1001 route 202
raritan, NJ 08869
9082188223
MDR Report Key6554460
MDR Text Key74990726
Report Number2250051-2017-00041
Device Sequence Number1
Product Code KSZ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6904577
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2016
Initial Date FDA Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-