MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION ANALYZER GEL; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number	6904577
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details: the customer stated that while refilling the saline/di container on the ortho vision id-mts, the operator noticed the smell of 70% alcohol upon opening the container.The customer suspects that 70% alcohol had been left on the analyzer from their weekly maintenance activities performed on 16oct2024.Upon discovery, on (b)(6) 2024, the customer cleaned the container, refilled with di water, and performed daily maintenance.Gtsc informed the customer that di water is used on the ortho vision id-mts analyzer when performing maintenance, during shutdown and when the analyzer comes out of an idle state to pre-flush the lines prior to the saline flush.Di water is not used directly during testing.The customer stated no erroneous results were reported.No further investigation was performed on these incidents.The assignable cause is user error, associated with the operator accidently utilizing 70% alcohol in place of deionized water.There was no evidence of any systematic failure of the ortho clinical diagnostics analyzer to perform as intended.No general failure of the ortho vision analyzer has been identified.No further complaints of this type have been received from the customer site since the time of the reported events.
Event or Problem Description
Cms (b)(4), windchill ra608034 complaint description: on 22oct2024, a customer contacted global technical solutions center (gtsc) to report that the operator used of 70% alcohol in place of deionized (di) water when refilling the container and the ortho vision id-mts analyzer (serial number (b)(6)) did not produce a system error.Complainant: (b)(6); (b)(6) hospital ((b)(6)); (b)(6), canada l6a 423 date of events: 16oct2024 at approximately 09:21am through 21oct2024, reported 22oct2024.Ortho vision mts analyzer (b)(6), installed: 19may2022 software version: 5.15.0 system fluids: expected - deionized (di) water actual - 70% alcohol the customer reported that no erroneous quality control (qc) or patient results were obtained between (b)(6) 2024.The customer stated that no biased results were reported to a physician.The customer reported that no patient was harmed as a consequence of the reported events.

• Brand Name: ORTHO VISION ANALYZER GEL
• Common Device Name: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20662229
• Report Number: 2250051-2024-00040
• Device Sequence Number: 20890849
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: (01)10758750012817(11)220519
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown