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 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated platelet results for one patient on the cell-dyn ruby analyzer.The following data was provided: sid (b)(6) initial 17,300 (consistent with the patients history), repeated 183,000, 17,300, 98,000.There was no impact to patient management reported.

Manufacturer Narrative

Discrepant hemoglobin data was provided for this patient on (b)(6) 2019 sid (b)(6) initial 7.58, repeat 7.63, 7.77, 7.77, 7.77, 7.58, 8.26, 7.94, 7.96 g/dl.The product evaluation is still in process.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The customer stated that the plt of 17,300 generated by cell-dyn ruby was consistent with the patients history.As no reference results (manual count, or manual plt estimate based on smear review) were provided, it is not possible to tell if the alternative method or the ruby result was truly correct.Based on all available information and abbott diagnostics' complaint investigation no product deficiency 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
• MDR Report Key: 8406471
• MDR Text Key: 142091925
• Report Number: 2919069-2019-00025
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

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
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/10/2019
• Supplement Dates Manufacturer Received: 03/20/2019; 05/19/2019
• Supplement Dates FDA Received: 03/22/2019; 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1