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

Catalog Number	04R13-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
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.Section a1 patient identifier completed information: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased wbc and neutrophil results generated on the cell-dyn analyzer for one sample.(customer provided reference values for wbc are 4 - 11 10e3/ul) the following results were provided: (b)(6) 2023 sid 24207537602 05:58 pm: wbc 0.5 10e3/ul neu 0.3 10e3/ul (b)(6) 2023 sid (b)(6) 06:26 pm repeat results: wbc 5.3 10e3/ul neu 3.6 10e3/ul the sample was repeated for the third time with the following results: (b)(6) 2023 sid (b)(6) 06:37 pm: wbc 5.3 10e3/ul neu 3.6 10e3/ul no impact to patient management was reported.
Additional Manufacturer Narrative
Updated information in section d4 primary udi number the complaint investigation for falsely decreased wbc and neutrophil results generated on the cell-dyn emerald analyzer, serial number (b)(6) included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Review of all the information provided by the customer was reviewed.Return testing was not completed as returns were not available.Review of the instrument service history reports records did not indicate any major repairs performed on the instrument.A ticket search did not identify an increase in complaint activity for the current issue.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency of the cell-dyn emerald analyzer for serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased wbc and neutrophil results generated on the cell-dyn analyzer for one sample.(customer provided reference values for wbc are 4 - 11 10e3/ul) the following results were provided: (b)(6) 2023 sid (b)(6) 05:58 pm: wbc 0.5 10e3/ul neu 0.3 10e3/ul (b)(6) 2023 sid (b)(6) 06:26 pm repeat results: wbc 5.3 10e3/ul neu 3.6 10e3/ul the sample was repeated for the third time with the following results: (b)(6) 2023 sid (b)(6) 06:37 pm: wbc 5.3 10e3/ul neu 3.6 10e3/ul no impact to patient management was reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 18491125
• Report Number: 2919069-2024-00004
• Device Sequence Number: 17939314
• Product Code: GKZ
• UDI-Device Identifier: 00380740136093
• UDI-Public: (01)00380740136093(21)546
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/05/2024

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 Catalogue Number: 04R13-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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