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

Catalog Number	09H59-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated platelet generated from a cell-dyn emerald and provided the following data for 2 patients: customer normal platelet range 140-442 k/¿l: patient 1 initial result was 1052 and repeat result was 268.Patient 2 initial result was 942 and repeat result was 322.Customer also reported that they did not report out the initial results, but rather the repeat results.Customer also states intermittently getting emergency stop and note the analyzer is rebooted which helps with resolution.It was reported that further troubleshooting was performed, which included replacement of analyzer parts and a sample was tested and generated platelet results which were similar to the recorded result of the sample.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Additional information received and a1 and b5 has been updated.Section a1: patient identifier - complete list of patient sample id's are (b)(6).
Event or Problem Description
The customer reported falsely elevated platelet generated from a cell-dyn emerald and provided the following data for 2 patients: customer normal platelet range 140-442 k/l.Patient 1 initial result was 1052 and repeat result was 268.Patient 2 initial result was 942 and repeat result was 322.Customer also reported that they did not report out the initial results, but rather the repeat results.Customer also states intermittently getting emergency stop and note the analyzer is rebooted which helps with resolution.It was reported that further troubleshooting was performed, which included replacement of analyzer parts and a sample was tested and generated platelet results which were similar to the recorded result of the sample.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.Additional information received.The customer provided further details for patient 1 and 2 samples.Patient 1 sample id was (b)(6) and on (b)(6) 2024 the initial platelet result was 1083 and repeat result was 268.Patient 1 sample id was (b)(6) and on (b)(6) 2024 the initial platelet result was 942 and repeat result was 322.
Additional Manufacturer Narrative
The cell-dyn emerald, serial number (b)(6) was evaluated.Replacement of the motor and sampling assembly addressed the emergency stop issue.The diluent was then replaced as it was noted to be low, and after multiple primes/flushes the issue was resolved.A review of tracking and trending did not identify a trend with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the cell-dyn emerald as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported falsely elevated platelet generated from a cell-dyn emerald and provided the following data for 2 patients: customer normal platelet range 140-442 k/l.Patient 1 initial result was 1052 and repeat result was 268.Patient 2 initial result was 942 and repeat result was 322.Customer also reported that they did not report out the initial results, but rather the repeat results.Customer also states intermittently getting emergency stop and note the analyzer is rebooted which helps with resolution.It was reported that further troubleshooting was performed, which included replacement of analyzer parts and a sample was tested and generated platelet results which were similar to the recorded result of the sample.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.Additional information received.The customer provided further details for patient 1 and 2 samples.Patient 1 sample id was (b)(6) and on (b)(6) 2024 the initial platelet result was 1083 and repeat result was 268 patient 1 sample id was (b)(6) and on (b)(6) 2024 the initial platelet result was 942 and repeat result was 322.

• Brand Name: CELL-DYN EMERALD 22 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: 20262970
• Report Number: 2919069-2024-00053
• Device Sequence Number: 8931607
• Product Code: GKZ
• UDI-Device Identifier: 00380740020286
• UDI-Public: (01)00380740020286
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K110381
• 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,Followup
• Report Date (Section B): 11/21/2024

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: 09H59-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 11/06/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/01/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2016
• 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: CD EMRLD 22 DIL, 09H62-01, UNKNOWN; CD EMRLD 22 DIL, 09H62-01, UNKNOWN; CD EMRLD 22 DIL, 09H62-01, UNKNOWN
• Patient Sex: Unknown