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

Catalog Number 6904577

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Discrepant negative gradings in antibody identification for one patient sample.Most probable root-cause is instrument related, the ortho vision biovue cims being misadjusted, preventing adequate gradings and the tip adaptor being corroded, preventing adequate dispensing.No general product failure was identified.No biased result was reported to a physician.The patient was not harmed.(b)(4).

Event Description

The complaint reporter is reporting discrepant negative gradings in antibody identification test for one patient sample using biovue technique on their ortho vision biovue analyzer.Complainant/complaint reporter: mrs.(b)(6) ¿ transfusion manager.Events dates: (b)(6) may 2017.Reported on: (b)(6) and 30 may 2017 by mrs.(b)(6) to the helpdesk.Software version: 4.8.0.Reagents: 0.8% resolve panel c lot 8rc523 exp.13 june 2017.Ortho biovue system igg cassette lot igc679a exp.27 october 2017.Ortho biovue system neutral cassette lot and expiry date not provided.Patient information: sample (b)(6).The customer said that, on (b)(6) 2017, they had tested a patient sample for antibody identification in iat technique using ortho biovue system igg cassette and 0.8% resolve panel c in conjunction with their ortho vision biovue analyzer ((b)(4)) and that they had obtained a weak positive reaction (with 0.5+ reaction strength) with cell 4, indeterminate error codes with cells 1, 8, 10, 11 and the auto-control column and negative reactions with cells 2, 3, 5, 6, 7 and 9 of the red cell reagent.The customer said when reviewing the reactions obtained in iat technique they would have graded reactions with cells 3, 6, 7 and 9 as weak positive reactions.The customer said that, on the same day, they had tested the same sample for antibody identification in enzyme technique using ortho biovue system neutral cassette and 0.8% resolve panel c in conjunction with the same analyzer and that they had obtained negative reactions with the 11 cells of the red cell reagent.The customer said that, on (b)(6) 2017, they had re-tested the same sample for antibody identification in iat technique using ortho biovue system igg cassette and 0.8% resolve panel c in conjunction with another of their ortho vision biovue analyzer ((b)(4)) and that they had obtained positive reactions with cells 1, 3, 4, 5, 6, 7, 8, 9, 10 and 11 and a negative reaction with cell 2 of the red cell reagent.No further detail was provided.The customer said when reviewing the reactions obtained in iat technique they agreed with the grading made by their ortho vision biovue analyzer.The customer said that, on the same day, they had re-tested the same sample for antibody identification using the same reagents in conjunction with their ortho vision biovue analyzer ((b)(4)) and that they had obtained negative reactions with five cells of the red cell reagent.No further detail was provided.The customer said when reviewing the reactions obtained in iat technique they would have graded the reactions obtained with three cells as weak positive reactions.No further detail was provided.The customer said that the antibody present in the sample was not identified.No further detail was provided.The customer said that no biased results were reported to a physician.The customer said that the patient was not harmed.

• 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: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 6649942
• MDR Text Key: 78031654
• Report Number: 2250051-2017-00051
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

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 Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• 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 Number: 1