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

Catalog Number 6904577

Device Problem False Positive Result (1227)

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

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The root cause of the unexpected sampling event observed by the customer is associated to a software anomaly.No biased result was reported to a physician.No patient was harmed.(b)(4).

Event Description

Customer contacted tsc to report an event of which they believed to be sample carryover from one known sample to another and giving a false positive antibody screening and incorrect blood type of another known patient sample.According to customer, two samples with previous history were loaded and tested together on the vision.Sample #1 had a previous blood type of group ab, rh positive with a positive abs screen with anti- e was identified.Sample # 2 had a previous blood type of group 0, rh positive with a negative abs screen.Because of the positive abs results for both samples and the same blood type of group ab, rh positive, additional testing was performed in manual method and sample #2 was confirmed to be group 0,rh positive and abs negative.Testing was repeated on vision in duplicate for sample #2 and again, the blood type was confirmed as group 0, rh positive and abs negative.Issue started on (b)(6) 2020; reported 8/14/2020.Tsc request copies of order reports of samples involved from customer on 18aug2020, tsc followed up with customer and discussed findings of barcode scan report, metering report column grade report that confirmed that sample with duplicate barcodes were loaded, but the software still allowed system to continue testing.As part of the investigation, the following information was noted using the different reports from vison analyzer: in using the barcode scan, it was noted that 2 samples had the same barcode.The attach error report indicated that apsw81 was generated, and the software was supposed to stop any processing, however, testing did continue.The user corrected the sample ids by moving sample #3 to position #5 which is now yellow and left sample #7 as is.The vision only processed sample now in position #5 and did not process the sample in position #7 because that sample id was originally in position #3 and all testing was completed.The metering report provided details on which sample was pipetted and their location on the rack.Column grade report provided the result of the sample ided and tested on the instrument.All samples were scanned using the laser or internal scanner, indicating that the tech loaded 2 samples with the same barcode and testing was completed with the alert of apsw81.

• 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 Contact: james a stevens ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 10497665
• MDR Text Key: 243893617
• Report Number: 2250051-2020-00043
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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