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

Catalog Number 6904577

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Event Description

The customer is complaining about what was described as incubation time been shorter than expected for tests requiring incubation at 37°c on their ortho vision® biovue analyser.Date of events: (b)(6) 2021 complainant/complaint reporter name: mr.(b)(6), laboratory technician reported on (b)(6) 2021 by mr.(b)(6) to ortho care reagents: ortho biovue® system ahg anti-igg cassette (product code 707400; lot igc102j; expiry date 20 august 2021; manufacturing date 23 december 2020) ortho biovue® system neutral (product code 707650; lot nec036f; expiry date 27 november 2021; manufacturing date 02 december 2021) non ortho liss (product code unknown; lot 6192; expiration date not provided) alba biovue screen j (product code albaz469; lot 1748; expiry date not provided) quality control (qc) ortho® brc set (product code 719816; lot brc0332; expiry date 26 may 2021) software version: 5.13.0 patient information: not provided the customer reported that between (b)(6) 2021, all patients and quality controls tested for antibody screening and crossmatch using the above listed reagents as applicable in conjunction with their ortho vision® biovue analyser had a shorten incubation time.No further detail was provided.The customer reported that no biased result was reported to the physicians.The customer reported that no patient was harmed because of these events.

Manufacturer Narrative

Incubation time shorter than expected for tests requiring incubation at 37°c on an ortho vision® biovue analyser the root cause is associated to a use error, the ortho field engineer having changed by mistake the value of the wrong command line in the ortho vision® biovue analyser application executable config file.No general product failure is identified.No biased result was reported to a physician.No patient was harmed.(b)(4).

• 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
• MDR Report Key: 11961352
• MDR Text Key: 281329610
• Report Number: 2250051-2021-00035
• 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
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1