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

Catalog Number	08H67-01
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	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 imprecise hemoglobin results generated on the cell dyn ruby for a neonatal patient sample.The following data was provided (customer¿s reference range 12.9-14.2 g/dl): initial result = 16.8 g/dl, repeat result = 6.75 g/dl no impact to patient management was reported.
Event or Problem Description
The customer observed imprecise hemoglobin results generated on the cell dyn ruby for a neonatal patient sample.The following data was provided (customer¿s reference range 12.9-14.2 g/dl): initial result = 16.8 g/dl, repeat result = 6.75 g/dl, no impact to patient management was reported.17oct2024 additional information was provided for patient previously reported on (b)(6) 2024 sample id (b)(6).Additional results provided: wbc initial result = 10.4 10e3/ul, repeat result = 13.6 10e3/ul, neutrophil initial result = 3.49, repeat result = 4.13, platelet initial result = 78.6 10e3/ul, repeat result = 129 10e3/ul.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Additional information in the following sections: section a1 - patient identifier updated from na to (b)(6).Section b3 - date of event updated from 9/4/2024 to 9/5/2024.Section b5 - describe event or problem updated with additional information provided.Section h4 - device mfg date updated from blank to 1/27/2021.
Event or Problem Description
The customer observed imprecise hemoglobin results generated on the cell dyn ruby for a neonatal patient sample.The following data was provided (customer¿s reference range 12.9-14.2 g/dl): initial result = 16.8 g/dl, repeat result = 6.75 g/dl.No impact to patient management was reported.17oct2024 additional information was provided for patient previously reported on.(b)(6) 2024 sample id (b)(6).Additional results provided: wbc initial result = 10.4 10e3/ul, repeat result = 13.6 10e3/ul.Neutrophil initial result = 3.49, repeat result = 4.13.Platelet initial result = 78.6 10e3/ul, repeat result = 129 10e3/ul.
Additional Manufacturer Narrative
The complaint investigation 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.The customer indicated the pediatric tube was filled to the top.Based on the tube type, customer service advised the customer to only fill to the 500 ul mark.Upon later follow-up, the customer confirmed that once he started filling the sample tube according to the procedure indicated, no other issues have been observed.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.Use error contributed to this event due to incorrect processing of the extraction/filling of the pediatric tube.Based on the investigation the cell-dyn ruby, serial number 71790bg is performing as intended, no systemic issue or deficiency was identified.

• Brand Name: CELL-DYN RUBY 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: 20255777
• Report Number: 2919069-2024-00052
• Device Sequence Number: 20828072
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061667
• 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,Followup
• Report Date (Section B): 11/20/2024

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: 08H67-01
• 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: 10/17/2024; 11/08/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/07/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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
• Patient Sex: Unknown