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

Model Number	04R1301
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
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.No specific patient information was provided.
Event or Problem Description
The customer obtained falsely depressed hemoglobin results while using the cell-dyn emerald 22 analyzer.The customer provided an example that the analyzer generated a hemoglobin result of 3 mmol/l instead of the correct value of 9 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Field service engineer (fse) visited the site, replaced counting chamber and the external power supply, however; the issue was not resolved.Fse performed a complete check of the system including shielding and all plug contacts, reinstalled software 1.1.5, performed annual maintenance, run precision and qc, all ok.A review of all tickets and a review for complaint trends for the list numbers were performed.The review did not identify any issues or trends.Device history record review did not identify any non-conformances or deviations related to the product and complaint issue.Labeling was found to adequately address the issue.Based on the investigation, no systemic issue or deficiency for the cell-dyn emerald 22 al analyzer, sn (b)(6), 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: 15491174
• Report Number: 2919069-2022-00030
• Device Sequence Number: 1918561
• Product Code: GKZ
• UDI-Device Identifier: 00380740136093
• UDI-Public: 00380740136093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 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: 09/16/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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