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	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated platelet results generated on the cell-dyn emerald analyzer for multiple samples.(b)(6) 2023, sid (b)(6) ,initial result = 1041, repeat result = 236; (b)(6) /2023 sid (b)(6) initial result = 979, repeat result = 415 no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 patient identifier complete information: (b)(6).Section e1 complete facility name: referencia de microtecnicas de laboratorio - morel all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated platelet results generated on the cell-dyn emerald analyzer for multiple samples.(b)(6) 2023 sid (b)(6) initial result = 1041, repeat result = 236.(b)(6) 2023 sid (b)(6) initial result = 979, repeat result = 415.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the cell-dyn emerald 22 al analyzer and cleaned the dilution cups.Autogain (vp-03 electronics gain adjustment) was run for wbc/rbc/plt with standardized latex particles, precision, and calibration were checked.Qc was within range.The fse recommended cleaning the top of the cups during weekly maintenance.Review of all the information provided by the customer was reviewed.Return testing was not complete as returns were not available.Specimen result reports were provided by the customer.The dispersional data alerts (h/h) accompanied suspect flags (s) with the platelet (plt) results.Some l1 and n2 flags were also noted, but p1, p2, and p3 flags were not observed.The results were flagged as suspect, indicating verification of results was required.A review of tracking and trending did not identify any trends associated with the complaint issue.Labeling was reviewed and adequately addresses the issue.Based on the investigation, the device met performance specification and performed as intended at the customer site, therefore there is no systemic issue or deficiency with the cell-dyn emerald 22 al analyzer, serial number (b)(6).All available patient information was included.Additional patient details are not available.

• 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: 17930120
• Report Number: 2919069-2023-00039
• Device Sequence Number: 12350482
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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