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

Catalog Number 6904577

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

No general product failure is identified.No biased results were reported to the physicians.The patients were not harmed.(b)(4).

Event Description

Customer is reporting a discrepant negative grading for major crossmatch and antibody identification for three patient samples in iat technique using ortho biovue technique in conjunction with their ortho vision biovue analyzer.Complainant/complaint reporter: mrs.(b)(6), biologist.Events dates: (b)(6) 2017.Reported on (b)(6) 2017 by mrs.(b)(6) to the helpdesk.Software version: 4.8.0.Reagents: ortho biovue system igg cassette lot igc663a exp.29 may 2017, ortho biovue system igg cassette lot igc668a exp.15 july 2017, 0.8% resolve panel c lot 8rc522 exp.16 may 2017, 0.8% red cell diluent lot rcd831 exp.16 november 2017.Patients¿ information: (b)(6).The customer reported that no biased result had been reported to the physicians and that the patients had not been harmed as a result of the reported events.

• 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 Key: 6575834
• MDR Text Key: 75737213
• Report Number: 2250051-2017-00042
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 05/18/2017

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: Health Professional
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/18/2017
• 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