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

Catalog Number	08H67-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased hemoglobin results generated on the cell-dyn ruby analyzer for one hemodialysis patient from multiple draws.The results provided were: on (b)(6) 2024 initial result on close mode=6.8 g/dl, repeated same specimen at another laboratory on (b)(6) 2024 (unknown platform) = 8.0 g/dl on (b)(6) 2024 two specimens drawn from the patient vein and catheter; vein r2v on open mode=6.6 g/dl; catheter r2c on open mode = 6.8 g/dl, repeated on 09feb2024 r2v=6.78 g/dl, sample repeated on blood bank ruby=7.17 g/dl ((b)(6)), same specimen process at another reference laboratory (unknown platform) =7.30 g/dl, after troubleshooting repeated = 6.67 g/dl on (b)(6) 2024 new specimen redrawn and repeated at another lab (unknown platform) =8.0 g/dl the customer reported the results questioned by the doctor, due to the low value, he asked that the patient be transfused; however, prior to the procedure, the result was corroborated and was higher, therefore the transfusion was canceled.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section a1 an evaluation is in process.A follow-up 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 falsely decreased hemoglobin results generated on the cell-dyn ruby analyzer for one hemodialysis patient from multiple draws.The results provided were: on (b)(6) 2024 initial result on close mode=6.8 g/dl, repeated same specimen at another laboratory on (b)(6) 2024 (unknown platform) = 8.0 g/dl on (b)(6) 2024 two specimens drawn from the patient vein and catheter; vein r2v on open mode=6.6 g/dl; catheter r2c on open mode = 6.8 g/dl, repeated on (b)(6) 2024 r2v=6.78 g/dl, sample repeated on blood bank ruby=7.17 g/dl (sn 54903bg), same specimen process at another reference laboratory (unknown platform) =7.30 g/dl, after troubleshooting repeated = 6.67 g/dl on (b)(6) 2024 new specimen redrawn and repeated at another lab (unknown platform) =8.0 g/dl the customer reported the results questioned by the doctor, due to the low value, he asked that the patient be transfused; however, prior to the procedure, the result was corroborated and was higher, therefore the transfusion was canceled.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely decreased hemoglobin results generated on the cell-dyn ruby analyzer for one hemodialysis patient from multiple draws.The results provided were: on (b)(6) 2024 initial result on close mode=6.8 g/dl, repeated same specimen at another laboratory on (b)(6) 2024 (unknown platform) = 8.0 g/dl.On (b)(6) 2024 two specimens drawn from the patient vein and catheter; vein r2v on open mode=6.6 g/dl; catheter r2c on open mode = 6.8 g/dl, repeated on (b)(6) 2024 r2v=6.78 g/dl, sample repeated on blood bank ruby=7.17 g/dl (sn (b)(6)), same specimen process at another reference laboratory (unknown platform) =7.30 g/dl, after troubleshooting repeated = 6.67 g/dl on (b)(6) 2024 new specimen redrawn and repeated at another lab (unknown platform) =8.0 g/dl the customer reported the results questioned by the doctor, due to the low value, he asked that the patient be transfused; however, prior to the procedure, the result was corroborated and was higher, therefore the transfusion was canceled.No impact to patient management was reported.
Additional Manufacturer Narrative
Updated information in section d4, primary udi number, additional information in section d10 - concomitant product.The field service representative replaced the hgb flow cell assembly of the cell-dyn ruby analyzer and adjusted the voltage value from 5.27v to 5.05v.After checking precision and calibration, a biocomparison test was performed and quality control passed.Review of the instrument service history for cell-dyn ruby serial number (b)(6) determined no further incidences were observed.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed.A review of tracking and trending did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the available information, no systemic issue or deficiency of the cell-dyn ruby for serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.

• 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 N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 18815536
• Report Number: 2919069-2024-00020
• Device Sequence Number: 4342836
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170(21)72342BG
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/24/2024

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: 02/09/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 05/23/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/15/2024; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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: ASSY, HGB FLOW CELL, CDRUBY, ROHS, 8921292204, UNK
• Patient Sex: Unknown