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

Model Number 08H67-01

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no specific patient information was provided.Investigation of the complaint issue included review of the incident and information provided by the customer, review of historical product data and labeling.The customer cleaned the cell-dyn ruby flowcell which resolved the issue.Review of complaint and trending data associated with the issue did not identify any trends or abnormal complaint activity.Based on the investigation, no deficiency or systemic issue was identified for the cell-dyn ruby analyzer.

Event Description

The customer obtained a falsely depressed hemoglobin result while using the cell-dyn ruby analyzer.On (b)(6) 2020 sample id (b)(6) generated an initial result of 3.94 g/dl.The sample was retested and was within the normal range.No impact to patient management was reported.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 10994548
• MDR Text Key: 223393262
• Report Number: 2919069-2020-00038
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• 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
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• 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: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1