MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN EMERALD SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number	09H39-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed discrepant hemoglobin (hgb) results generated on the cell-dyn emerald for a patient sample.The following data was provided: (b)(6) 2023 sample id (b)(6) initial hgb run at labcorp = 7.9 g/dl (reference range 11.1-15.9 g/dl), repeat on emerald = 9.2 g/dl (reference range 12.0-15.5 g/dl) no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed discrepant hemoglobin (hgb) results generated on the cell-dyn emerald for a patient sample.The following data was provided: on (b)(6) 2023 sample id (b)(6) initial hgb run at labcorp = 7.9 g/dl (reference range 11.1-15.9 g/dl), repeat on emerald = 9.2 g/dl (reference range 12.0-15.5 g/dl) no impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date updated from blank to 6/23/2021 section d10 - concomitant product updated from blank to counting chambers w/o aperture, 8701685903, unknown.The complaint investigation for discrepant red blood cell (rbc) count results generated on the cell-dyn emerald included a review of data and information initially provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.The field service representative (fsr) inspected the instrument and replaced the counting chambers w/o aperture part.Replacement of the part resolved the issue.Return testing was not completed as returns were not available.There were no service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.An instrument service history review revealed no additional erratic or discrepant patient results reported for the cell-dyn emerald analyzer.A review of tracking and trending of the cell-dyn emerald did not identify any trends associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the cell-dyn emerald for serial 10176, or the counting chambers w/o aperture was identified.Section g1 with corrected/updated information.

• Brand Name: CELL-DYN EMERALD SYSTEM
• 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 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17606990
• Report Number: 2919069-2023-00027
• Device Sequence Number: 17719121
• Product Code: GKZ
• UDI-Device Identifier: 00380740020088
• UDI-Public: 00380740020088
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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 Catalogue Number: 09H39-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COUNTING CHAMBERS W/O APERTURE, 8701685903, UNKNOW
• Patient Sex: Unknown