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

Catalog Number	08H67-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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.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 elevated hemoglobin (hgb) and hematocrit (hct) results for one patient on a cell-dyn ruby analyzer.The following data was provided: sample id (b)(4).Initial hgb result was 23.6, repeat results were 15.1 and 15.3 g/dl; initial hct result was 71.4, repeat results were 46.9 and 47.5%.There was no impact to patient management reported.
Event or Problem Description
The customer observed elevated hemoglobin (hgb) and hematocrit (hct) results for one patient on a cell-dyn ruby analyzer.The following data was provided: sample id (b)(6) initial hgb result was 23.6, repeat results were 15.1 and 15.3 g/dl; initial hct result was 71.4, repeat results were 46.9 and 47.5%.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated hemoglobin and hematocrit results generated on the cell-dyn ruby analyzer, serial number (b)(6), included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.Trending review determined no related trend for the product.Return testing was not completed as returns were not available.Review of the data found that seq 7560 had wbc, rbc, hgb, hct, mch, and plt parameters flagged as out of range.Seq 7561 and 7562 had results similar in range of each other.When comparing the first run to the subsequent two runs, the wbc concentration was lower, rbc and hgb concentrations were higher, and plt concentration was lower.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the cell-dyn ruby analyzer, serial number (b)(6), 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: 19212805
• Report Number: 2919069-2024-00027
• Device Sequence Number: 20587208
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 04/10/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• 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