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

Catalog Number	04R13-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 hemoglobin results on the cell dyn emerald analyzer for one patient.The following results were provided (reference range 13.5 to 18 g/dl):.Hemoglobin result (cell dyn emerald)= 10 g/dl and 12 g/dl; hemoglobin result (cell dyn ruby)= 6.5 g/dl, 5.5 g/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the cd-emerald 22 analyzer, serial number (b)(6), and discovered the piston dia 1.6 had loose screws, causing imprecise movements.The fsr tightened/adjusted the screws on the piston dia 1.6, which resolved the issue.Return testing was not completed as returns were not available.The instrument service history for the cd-emerald 22 analyzer verifies no subsequent issues have been reported related to falsely elevated hemoglobin results after the current issue was identified.A review of tracking and trending of the cd-emerald 22 analyzer did not identify an increase in complaint activity associated with the complaint issue.Additionally, a review of tracking and trending for the piston dia 1.6 did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cd-emerald 22 analyzer for serial number (b)(6) or the piston dia 1.6 was identified.
Event or Problem Description
The customer observed falsely elevated hemoglobin results on the cell dyn emerald analyzer for one patient.The following results were provided (reference range 13.5 to 18 g/dl): hemoglobin result (cell dyn emerald)= 10 g/dl and 12 g/dl; hemoglobin result (cell dyn ruby)= 6.5 g/dl, 5.5 g/dl.There was no impact to patient management 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 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22096240
• Report Number: 2919069-2025-00021
• Device Sequence Number: 20559405
• Product Code: GKZ
• UDI-Device Identifier: 00380740136093
• UDI-Public: (01)00380740136093
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K190294
• 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): 06/19/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: PISTON DIA 1.6, 8701688901, UNKNOWN; PISTON DIA 1.6, 8701688901, UNKNOWN
• Patient Sex: Unknown