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	08/23/2024
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.
Event or Problem Description
The customer observed imprecise hemoglobin results generated on the cell dyn ruby analyzer for one pediatric sample.The following data was provided: cbc rrbc mode hemoglobin result was 7.94; the result from the previous day was 11.Repeated again and the result was 11.5; using the gasometer the result was 6.7.They reprocess cbc + rrbc in ruby giving 6.75, cbc + noc gives 6.8.No impact to patient management was reported.
Additional Manufacturer Narrative
Field service activity indicated that fluid movement of the shear valve was not as expected.The shear valve driver assembly (part 8921204904) was replaced, and the complaint issue was resolved.The complaint investigation included a review of data and information provided by the customer.Two pictures (screenshot and printout) of the same run (sequence 9901) were provided by the customer.In open cbc+rrbc mode, suspect results with invalidated neu and eos results were generated on the cell-dyn ruby on 23 august 2024 with dflt (ne) flagging.All rbc-related parameters except mcv and mchc were marked with dispersional data alerts.As stated in section 2, installation procedures and special requirements, under dispersional data alerts, of the cell-dyn ruby system operator's manual (800673r02): a result that falls outside a laboratory action limit can also indicate the need for the operator to follow a laboratory protocol, such as repeating the specimen, notifying the physician or performing a smear review.In cases where a cellular abnormality is present that alters cellular morphology to the point that the cells do not fit the criteria used by the instrument to generate a flag, dispersional data alerts may be the only flag(s) that will alert the operator to a potentially erroneous result.A review of all complaints associated and a review of complaint trends was performed.The review did not identify any trends.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed imprecise hemoglobin results generated on the cell dyn ruby analyzer for one pediatric sample.The following data was provided: cbc rrbc mode hemoglobin result was 7.94; the result from the previous day was 11.Repeated again and the result was 11.5; using the gasometer the result was 6.7.They reprocess cbc + rrbc in ruby giving 6.75, cbc + noc gives 6.8.No impact to patient management was reported.

• 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: 20171589
• Report Number: 2919069-2024-00051
• Device Sequence Number: 7002980
• 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
• Report Date (Section B): 11/04/2024

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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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