MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO VERSEIA® PIPETTER; AUTOMATED PIPETTOR

Catalog Number 5561701

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Mxp2473671 qerts 515058.Email address for contact office above is: (b)(6).Investigation details - plate reports, sample audit trail and plate loadlist reports were provided by ortho am to aid in the investigation.Ortho care tsc reviewed all reports and identified the sample with combined barcode id was utilized on 3 assays.Further review of the plate loadlist report indicated the sample with erroneous id was loaded utilizing the handheld barcode scanner and was not scanned automatically by the verseia pipetter software.No erroneous results were reported.Samples were identified during result review.Results were invalidated and sample was to be reloaded for repeat testing.Customer was referred to the vip user guide chapter 7-21 to review procedure for resolving barcode read errors when samples are loaded onto verseia.No further investigation was performed.The assignable cause is associated with user error, the customer utilized the handheld scanner to manually assign location without verifying sample id.No general product failure is identified.The customer has reported no other similar incident since monitoring period.Investigation summary: sample barcode was not displaying as expected on verseia pipettor.Barcode misread suspected by customer.The most probable assignable cause is associated with a use error, the customer not following the procedure for manually loading samples with barcode read errors during autoload process.No general product failure is identified.Testing was performed on 3 assays, but no biased results were reported to providers.No patient/donor was harmed.

Event Description

An ortho employee communicated a customer complaint for barcode misread on the verseia pipettor to ortho care technical support.Customer states verseia pipettor combined two sample barcodes on one donor sample when being loaded onto the instrument.Date of event: (b)(6) 2022.Complaint reporter: (b)(6).Reported on (b)(6) 2022 by (b)(6).Ortho verseia pipettor (product code: 5561701), s/n: (b)(4).Patient information: not applicable.Sample information: ortho hcv plate id ¿ dc0380 position (sample id (b)(6).Gs hiv-1/2 plus plate id ¿ aj3796 position (sample id (b)(6).Gs hbsag plate id ¿ bk7316 position (sample id (b)(6).

• Brand Name: ORTHO VERSEIA® PIPETTER
• Type of Device: AUTOMATED PIPETTOR
• 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: 15675228
• MDR Text Key: 307005312
• Report Number: 2250051-2022-00063
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5561701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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