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

Model Number 08H67-01

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated platelet results on cell-dyn ruby analyzer for one patient.The results provided were: sid (b)(6) initial=1118 k/ul /repeated=129 k/ul there was no reported impact to patient management.

Manufacturer Narrative

Complete patient information, 1.Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The customer observed discrepant platelet results on two patient samples on cell-dyn ruby analzyer.The issue was found due to leakage from cd32k inline fltr, list number 06h92-01, lot number unknown.The complaint issue did not recur after replacement of the cd32k inline fltr.There were no customer returns available for this investigation.A review of service complaints for the cell-dyn ruby analyzer and cd32k inline fltr did not identify any other complaints or trends for this issue.A review of the cell-dyn ruby system operator¿s manual provides steps on how to replace the diluent/sheath filter and states to, "replace the filter once a month, or whenever contamination is suspected.A sign of contamination is usually manifested by high platelet background, poorly defined plt-rbc (0°/10°) scatterplot, excessive wbc flagging, or erroneous 5-part differential results." the manual further states in section 10, "troubleshooting and diagnostics," that, "generally, conditions that are instrument- or reagent-related will occur on all samples, including controls.Therefore, if a problem is detected or suspected, it is important to confirm instrument performance by rerunning controls.Based on this investigation a product deficiency was not identified for cell-dyn ruby analyzer, list number 08h67-01, serial number (b)(6) or cd32k inline fltr.

• Brand Name: CELL-DYN RUBY SYSTEM
• Type of Device: 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: 13905254
• MDR Text Key: 292742065
• Report Number: 2919069-2022-00007
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1