MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD 22 AL, INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	04R1301
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The account stated the cell-dyn emerald 22 al did not read some sample barcodes properly.The account stated that when some barcodes were read, it did not read them correctly and showed "no patient id" in their ams.This happened for approximately 4 specimens out of 30 total.Examples provided: cd emerald read: wr478899 but should have been wh478899.Cd emerald read: wh4s7837 but should have been wh477837.The account stated the same sample tubes that did not read properly were processed on another cell-dyn emerald which read the barcodes properly.The samples were read using the auto-loader.The account uses barcode type code 39 without check digit.The analyzers are connected to lis/middleware ams and receive orders from the ams.The account stated the analyzers were just put into use/went live the day before.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.
Additional Manufacturer Narrative
A review of all service and complaint tickets associated with the cell-dyn emerald 22 al and a review of complaint trends for the list number was performed.The review did not identify any adverse trends and the complaint activity was normal for the lot.Additionally, labeling was reviewed and adequately addressed the issue under review.No product deficiency was identified.

• Brand Name: CELL-DYN EMERALD 22 AL, INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15283559
• Report Number: 2919069-2022-00022
• Device Sequence Number: 19449794
• Product Code: GKZ
• UDI-Device Identifier: 00380740136093
• UDI-Public: 00380740136093
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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: 04R1301
• Device Catalogue Number: 04R13-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 11/29/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/30/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown