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

Model Number	04R1301
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated platelet results for several patients on a cell-dyn emerald analyzer.The following data was provided (customer¿s reference range is (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6) all available patient information was included.Additional patient details are not available.Section b5 updated to include the sample ids provided by the customer.Section b5 patient #1 updated to sample id (b)(6) and patient #3 updated to sample id (b)(6).
Event or Problem Description
The customer observed falsely elevated platelet results for several patients on a cell-dyn emerald analyzer.The following data was provided (customer¿s reference range is 130-440 10e3/ul): sample id (b)(6) initial result was 1214, repeated on a siemens analyzer was 437 10e3/ul.Sample id (b)(6) initial result was 908, repeated on a siemens analyzer was 308 10e3/ul.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated platelet results generated on the cell-dyn emerald analyzer, serial number (b)(6), when compared to results from a siemens analyzer, 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.Trending review determined no related trend for the product.Return testing was not completed as returns were not available.The cell-dyn emerald 22 al does not have limits factory set.It is the responsibility of each laboratory to determine limit sets appropriate for its patient population.It was noted that the customer did not set up the limits, therefore, they did not receive any flags.The issue was resolved by performing back flush on the instrument.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the cell-dyn emerald analyzer, serial number (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, IL N39 E-932 ; 2246682940
• MDR Report Key: 12586430
• Report Number: 2919069-2021-00020
• Device Sequence Number: 19740973
• Product Code: GKZ
• UDI-Device Identifier: 00380740136093
• UDI-Public: 00380740136093
• 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,Followup
• Report Date (Section B): 01/10/2022

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
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 12/17/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/21/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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