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	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary quality control (qc) testing was not run after a daily maintenance with their ortho vision id-mts analyzer.The assignable cause is a use error, the customer not following their site's protocol.No general product failure was identified.No biased results obtained and/or reported to the physicians.No patient was harmed because of this event.Investigation details per (b)(4): using connectivity, gtsc found that: daily maintenance was performed as follows: 24 may 2024 at 8:29:32 pm 25 may 2024 at 4:59:16 am (additional) 25 may 2024 at 8:24:39 pm 26 may 2024 at 7:36:05 pm qc was run as follows: 24 may 2024 at 9:20 pm 25 may 2024 at 3:58 pm and again at 8:53 pm 26 may 2024 at 8:03 pm thus, it is concluded that on 25 may 2024, the quality control (qc) was still valid per settings for qc interval.It was explained to the customer that ortho vision id-mts analyzer software can only force qc based off the interval setting, not based off maintenance tasks.Ortho vision id-mts analyzer worked as per design.Gtsc advised customer that in this situation, qc would need to be manually ordered and ran.No further investigation was carried out on this incidence.The assignable cause of qc testing not run after a daily maintenance is a use error, the customer not following their site's protocol.There is no evidence of any systematic failure of the ortho analyzer to perform as intended.No other complaint of this type has been received from the customer site since the time of the reported event.
Event or Problem Description
Cms 2635536, windchill (b)(4) a customer contacted global technical solution center (gtsc) on 10 july 2024 to report that quality control (qc) testing was not run after a daily maintenance with their ortho vision id-mts analyzer serial (b)(6) equipped with software version 5.15.0.Complainant/complaint reporter name: (b)(6) event date: 25 may 2024.The customer reported that on 25 may 2024, they had performed an additional daily maintenance as part of troubleshooting at 4:59:16 am, outside of normal maintenance schedule/time.Per customer's local policy, qc is required to be completed any time daily maintenance is performed.The customer stated that qc was not run following this additional maintenance on 25 may 2024.The customer stated that they were not satisfied with the fact that their ortho vision id-mts analyzer allowed samples to be run and reported until 3:58 pm the same day.The customer reported that all results obtained with their ortho vision id-mts analyzer were accurate, thus, the customer confirmed that no patient was harmed because of this event.The customer stated that the incident was reported to the fda due to local quality control policy not being followed.

• 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: 19906349
• Report Number: 2250051-2024-00029
• Device Sequence Number: 15621632
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: (01)10758750012817(11)180831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2024

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: 07/10/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2018
• 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