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

Model Number	04R1301
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased platelets generated on the cell-dyn emerald for a patient with autoimmune thrombocytopenic purpura.The following data was provided: on (b)(6) 2023, sample id (b)(6); initial result on the ruby (serial number (b)(6)) = 6.08 10e3/ul, initial result on emerald = 15 10e3/ul, repeat = 12 10e3/ul.The physician questioned both of these results and sent them to other laboratories for testing.The same sample (sid (b)(6)) processed at (b)(6) hospital, result = 75 10e3/ul, and processed at (b)(6) laboratory, result = 33 10e3/ul.The patient was discharged with treatment.No negative 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 falsely decreased platelets generated on the cell-dyn emerald for a patient with autoimmune thrombocytopenic purpura.The following data was provided: (b)(6) 2023 sample id (b)(6) initial result on the ruby (serial number (b)(6)) = 6.08 10e3/ul initial result on emerald = 15 10e3/ul, repeat = 12 10e3/ul.The physician questioned both of these results and sent them to other laboratories for testing.The same sample ((b)(6)) processed at angeles pedregal hospital, result = 75 10e3/ul, and processed at biomedicos laboratory result = 33 10e3/ul.The patient was discharged with treatment.No negative impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date.The complaint investigation for falsely decreased platelet (plt) results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A screen shot of the cell-dyn emerald 22 al, serial number (s/n) (b)(6) laboratory pages were submitted for review.The customer indicated that some giant platelets were observed on the smear; however, smear images were not provided by the customer.The plt histogram on the cell-dyn emerald 22 al did not show normal distribution.L1/n1/n2/p2 flagging on the cell-dyn emerald 22 al indicated a possibility of plt aggregates.Based on the information provided, the cell-dyn emerald 22 al marked the plt results suspect and generated flags, indicating that verification of the results was required.A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any trends.Labeling was reviewed and found to adequately address the issue under review.Based on this investigation, the device met performance specifications and performed as intended at the customer site.No systemic issue or deficiency with the cell-dyn emerald 22 al, 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16718582
• Report Number: 2919069-2023-00012
• Device Sequence Number: 7237803
• 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
• Report Date (Section B): 05/24/2023

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 Model Number: 04R1301
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: CD EMRLD 22 DIL, 09H62-01,; CD EMRLD 22 DIL, 09H62-01,
• Patient Sex: Unknown