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

Catalog Number 08H67-01

Device Problem High Test Results (2457)

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

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

The evaluation included a review of submitted data, product historical data, and product labeling.A review of complaint and trending data did not identify any issues or trends.The submitted data was reviewed and found that the initial closed-mode results generated on the cell-dyn ruby, matched the results generated on the alternate analyzer for all major parameters, including wbc, rbc, hgb, mcv, and plt.However, when the results from the repeat run in open mode on the cel-dyn ruby a difference was observed.The results were higher for rbc and hgb and lower for wbc and plt, which may be indicative that further mixing of the specimen was necessary.A review of the product labeling concluded that the issue is sufficiently addressed.No systemic issue or deficiency of the cell-dyn ruby analyzer was identified.

Event Description

The account generated an initial hemoglobin patient result of 7.89 g/dl and repeat result of 11.8 g/dl when processing on the cell-dyn ruby.The customer ran the sample on a back up analyzer (initial result 7.8 g/dl and repeat result 7.6 g/dl).No impact to patient management reported.Ethnicity and race was not provided.

• 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: 7975231
• MDR Text Key: 126094898
• Report Number: 2919069-2018-00051
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2018

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?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 89 YR