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

Catalog Number 08H67-01

Device Problem Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).

Event Description

The customer observed evidence of charring on a ribbon cable of the cell-dyn ruby analyzer.No injuries have been reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, field service evaluation, a search for similar complaints, and a labeling review.The abbott field service engineer (fse) evaluated the issue on site and found that the cable assy was tucked between the side gate and the cell-dyn ruby frame causing a pinch in the cable.Inspection of the return cable was evaluated and showed one specific line (ground line) of the cable was cut due to pinching and may have been shorted (evidence of charring).The damage found in the ground line of the cable would not affect the sample processing performance of the cell dyn ruby analyzer.No adverse trends were identified for the part in question, as this was the only documented event for this type of incedent.Labeling was reviewed and found to be adequate, as it contains instructions regarding electrical hazard awareness and elements of electrical safety information relevant to the complaint incident.Based on the available information no product deficiency of the cell-dyn ruby analyzer, list number 08h67, and the related cable assy, was identified.

• 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: 5401397
• MDR Text Key: 37739587
• Report Number: 2919069-2016-00004
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• 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?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2006
• 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