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

Catalog Number 08H00-01

Device Problem High Test Results (2457)

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

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

No further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated neutrophil results generated on the cell-dyn sapphire for 1 sample.The following data was provided: (b)(6) 2019 sid (b)(6).Initial neutrophils = 0.504 (504 cells/ul), repeat = 0.017 (17 cells/ul), repeat on ruby = 0.007 (7 cells/ul).Data invalidating flags were generated with the ruby results indicating the need to confirm the results.No flags were generated on the sapphire results.

Manufacturer Narrative

The field service representative (fsr) was on site and suspected carry over from sequence 7100 to 7101 possibly due to insufficient rinse from wbc mix potfield.The fsr confirmed normal functioning of pinch values in the wbc fluidics pathway and ran 3 additional carryover studies which all passed.No additional carryover/discrepant have occurred since this event.Further investigation of the customer issue included a review of the complaint text, review of product historical data, device history record review and a review of labeling.This review did not find any abnormal complaint activity and no trends were identified.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the cell-dyn sapphire analyzer was identified.

• 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: 9383918
• MDR Text Key: 190383534
• Report Number: 2919069-2019-00113
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2020

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: 08H00-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1