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

Catalog Number 08H00-01

Device Problem Low Test Results (2458)

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

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

There is no further patient information provided due to privacy issues.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported that the cell dyn sapphire analyzer was generating wbc count rate violations.The customer stated they had one falsely depressed wbc on one patient.The results provided were: (b)(6) 2019 sid (b)(6) wbc = 0.281 / repeated on second analyzer = 10.0.There was no reported impact to patient management.

Manufacturer Narrative

The investigation included review of customer submitted data, product historical data, and product labeling.During the requested site visit, the field service engineer (fse) identified a small hole in the tubing between the wbc mix cup and valve 225, which was replaced.Return testing was not completed as returns were not available.A review of historical data did not find a product issue related to the complaint incident.A review of the historical data on the cell dyn sapphire, serial number (b)(4), found no other complaints related to this issue after the fse replaced the tubing.The customer's submitted data showed that the results for the wbc were suppressed and the differential parameters were underlined.These results require further verification per the cell-dyn sapphire operator's manual before being reported out of the laboratory.Labeling review was found to be adequate for the complaint incident.Based on the investigation no product deficiency was identified for the cell dyn sapphire, sn (b)(4).

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8962098
• MDR Text Key: 184178488
• Report Number: 2919069-2019-00101
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1