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 04/02/2017

Event Type  malfunction  

Manufacturer Narrative

Most probable root-cause of the automatic acceptance of the weak positive a(abo1) antigen typing result is associated with an incorrect analyzer configuration.No general product failure is identified.No biased result was reported to physician.The patient was not harmed.(b)(4).

Event Description

The customer is reporting a discrepant weak positive a(abo1) antigen typing result for one patient sample using ortho biovue technique in conjunction with their ortho vision biovue analyzer.Complainant: (b)(6) (position not provided).Complaint reporter: (b)(6) ¿ ortho laboratory specialist.Event date: (b)(6) 2017.Reported on: 06 april 2017 by (b)(6) to (b)(6) who reported it to the helpdesk on the same day.Patient information: pregnant women; known to be o rhd negative.Software version: 4.8.0.Reagent: ortho biovue system abd-rum 1 confirmation cassette lot ndc149a exp.21 july 2017.The customer reported that, on (b)(6) 2017, they had tested a patient sample for abd confirmation typing using ortho biovue system abd-rum 1 confirmation cassette lot ndc149a in conjunction with their ortho vision biovue analyzer and that they had obtained a weak positive reaction (0.5+ reaction strength) with biovue anti-a(abo1) reagent and negative reactions with biovue anti-b(abo2) and d(rh1) reagents.The customer reported that upon visual inspection of the cassette image, they would have graded the reaction with biovue anti-a(abo1) reagent as negative.The customer said that an a blood group result was automatically accepted and transferred to their laboratory information system (lis) where the result was blocked.The customer said that they had repeat-tested the same sample using the same reagent lot and analyzer and that they had obtained the expected o group.The customer reported that no biased result had been reported to a physician and that the patient had not been harmed as a result of the reported event.

• 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: 6543899
• MDR Text Key: 74606491
• Report Number: 2250051-2017-00039
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/04/2017

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
• Device Lot Number: 4.8.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/04/2017
• 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
• Treatment: N/AP