MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H67-01

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

A product correction letter was sent to cell-dyn ruby customers who have instruments with the affected printed circuit board assemblies (pcbas).A mandatory technical service bulletin (tsb) was issued on all impacted cell-dyn ruby analyzers.The mandatory tsb instructs field service to replace the pcba pump relay board.

Event Description

Field service replaced the pcba pump relay board on the cell-dyn ruby analyzer.There was no impact to patient results.

Manufacturer Narrative

Further review indicates that the replacement of the printed circuit board assembly (pcba) for this instrument occurred prior to the field action decision.This instrument is not in the scope of the field action and no mdr is required.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6374397
• MDR Text Key: 68979524
• Report Number: 2919069-2017-00029
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)00380740017170
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2919069-02/13/17-001-C
• Patient Sequence Number: 1