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 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.

• 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: 6554460
• MDR Text Key: 74990726
• Report Number: 2250051-2017-00041
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/09/2017

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 Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 05/09/2017
• 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 Number: 1