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 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

Discordant negative antibody screening, identification and major cross-match results for three patients having an anti-e(rh3) antibody during a customer demonstration.The root-cause could not be determined.No general product failure is identified.No biased result was reported to a physician.The patients were not harmed.

Event Description

A customer complained after obtaining what was described as discordant antibody screening, identification and/or cross-match results for three patients using the ortho biovue system in conjunction with an ortho vision biovue analyzer during a customer demonstration.Date of events: (b)(6) 2017.Complainants: (b)(6)¿ laboratory managers.Complaint reporter: (b)(6)¿ ortho laboratory specialist.Reported on (b)(6) 2017 by (b)(6) to (b)(6) who reported it to ortho care helpdesk on the same day.Reported on (b)(6) 2017 by (b)(6) to (b)(6) who reported it to ortho care helpdesk on (b)(6) 2017.Reagents: ortho biovue system poly cassette lot ahc613a expiry date 18 november 2017.Ortho biovue system poly cassette lot ahc615a expiry date 01 december 2017.0.8% surgiscreen lot 8ss9041 expiry date 13 june 2017.0.8% resolve panel a lot 8ra8030 expiry date 13 june 2017.Ortho bliss lot 280504 expiry date 13 february 2019.Software version: 4.8.0.Patient information: patient 1: known to have an anti-e(rh3) antibody.Patient 2: known to have a mix of anti-d(rh1) and anti-e(rh3) antibodies.Patient 3: known to have an anti-e(rh3) antibody.The customer reported that on (b)(6) 2017, during a customer demonstration, they had tested a sample from patient 1 for antibody identification in iat using 0.8%resolve panel a lot 8ra8030 and ortho biovue system poly cassette lot ahc613a in conjunction with their ortho vision biovue analyzer and that they had obtained negative reactions with the 11 cells of the red cell reagent.The customer reported they could not identify the anti-e(rh3) antibody.The customer reported that on the same day, they had tested this same sample from patient 1 for major cross-match testing with a donor known to be e(rh3) antigen positive using ortho biovue system poly cassette lot ahc613a and ortho bliss lot 280504 in conjunction with their ortho vision biovue and that they had obtained an unexpected negative/compatible reaction.The customer reported that on (b)(6) 2017, they had tested a sample from patient 2 for antibody identification in iat using the same reagents and analyzer and that they had obtained positive reactions (3+ reaction strength) with cells 1, 2, 3, 4 and 11 and negative reactions with the other 6 cells of the red cell reagent.The customer reported they could not identify the anti-e(rh3) antibody but only the anti-d(rh1) antibody.The customer reported that on (b)(6) 2017, they had tested a sample from patient 3 for antibody screening in iat using 0.8%surgiscreen lot 8ss9041 and ortho biovue system poly cassette lot ahc615a in conjunction with their ortho vision biovue analyzer and that they had obtained negative reactions with the 3 cells of the red cell reagent.The customer reported they could not detect the anti-e(rh3) antibody.The customer reported that the 3 samples tested had given positive results with an alternative commercially available method (bio-rad).No further detail was provided.The customer reported that no biased result had been reported to a physician.The customer reported that no patient had 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 (Section G): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 6751229
• MDR Text Key: 82302937
• Report Number: 2250051-2017-00058
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/28/2017

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 Expiration Date: 11/18/2017
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2017
• 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