MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO VISION ID-MTS ANALYZER; 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 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Mxp2408087.Qerts# 502016.Email address for contact office (b)(6).False negative forward typing for one patient was reported to a clinician.The assignable cause is user error where the customer scanned a barcode of one sample and then physically loaded a different sample into that position.The reported biased results were corrected prior to any further action taken.No general product failure was identified.No patient was harmed.

Event Description

Customer reported a single patient produced a false blood group of o pos when tested in the abd/rev card on vision analyzer on (b)(6) 2022.Patient had a history of blood type ab positive.Customer tested another sample from the same patient for an abo confirmation which resulted in the expected ab pos.This prompted customer to repeat testing on initial patient sample and ab pos results attained.Customer reports alba q qc lot# v242465; (b)(6) 2022 not affected.Sw: 5.12.4 sample id: (b)(6).Econn encryption id # (b)(6).Repeat testing on vision gave ab pos results using the same listed reagents.Customer tested with mts abd/rev gel card lot# 080421037-06 exp: 5.19.22,.Customer tested with 0.8% affirmagen lot# affirmagen 8a374 exp: 1.25.22.

• Brand Name: ORTHO VISION ID-MTS ANALYZER
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 13307974
• MDR Text Key: 295324791
• Report Number: 2250051-2022-00002
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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