MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VERSEIA PIPETTER; AUTOMATED PIPETTOR

Model Number	5561701
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plate reports provided by the customer to show the barcode scan error and the other plates tested that day were provided for comparison and showed that no other scanning errors had occurred.No erroneous results were reported.Testing was repeated and released to the customers lis as expected.The customer will be referred to the vip user guide chapter page 7-21 to review the procedure for resolving barcode read errors when samples are loaded onto verseia.A query of the worldwide complaint database was performed from (b)(6) 2022 through to (b)(6) 2023 for call subject zbcscan and call area bcmisred.No other complaint was identified.No trend is identified.The assignable cause is associated to operator use error when manually scanning the samples to position during loading.No general product failure is identified.The customer has reported no other similar incident since.
Event or Problem Description
Hold cc 4.5 mxp2512587; ra601553 on (b)(6) 2023, a customer contacted orthocare to report what was described as a barcode misread scanning issue on their verseia pipettor.The customer stated that their verseia pipettor combined two sample barcodes into one when being loaded onto the instrument.The customer reported that, on (b)(6) 2023, they were manually scanning the barcodes on samples loaded to test for gs hiv-1/2 plus plate id ¿ aj2017 when they accidentally scanned two barcodes next to each other (sample id (b)(6) and (b)(6) resulting in a new sample id being uploaded as (b)(6).Testing was completed under the combined sample id.Once identified, the customer stated that sample (b)(6) was able to be repeated with no issues as the barcode was unique to the oas and it was the first time it was recognized in the software.Since sample id (b)(6) had already been processed originally as a single barcode scan, a draw site had to be assigned for repeat hiv testing to be allowed by the oas as a unique sample id.The customer stated that upon completion of the testing, they chose to prevent the results from samples (b)(6) and (b)(6) from being released to the lis and to repeat the hiv testing.The customer confirmed that no biased result was obtained or reported.The customer confirmed that no patients/donors were harmed.

• Brand Name: ORTHO VERSEIA PIPETTER
• Common Device Name: AUTOMATED PIPETTOR
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16682406
• Report Number: 0002250051-2023-00085
• Device Sequence Number: 8172034
• Product Code: MZA
• UDI-Device Identifier: 10758750013265
• UDI-Public: 10758750013265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/04/2023

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 Model Number: 5561701
• Device Catalogue Number: 5561701
• 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: 03/21/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• 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