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 09/09/2019

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 falsely depressed platelet (plt) results on one patient generated on the cell dyn sapphire analyzer.The results provided were: on (b)(6) 2019 (b)(6) plt = 16.9 / 28.7 / on a different sapphire = 29.4.The patient was admitted to the hospital based on the 16.9 result, but no treatment occurred.There was no reported impact to patient management.

Manufacturer Narrative

A review of product historical data for trends and similar customer complaints received for this issue did not identify any trends and only one other complaint for a similar issue.A review of customer provided data showed that platelet results were suspect or invalid, due to the data flags (underlined mpv, pdw and pct and "lower, upper, or lower and upper region interference in plti histogram" flag).It appears that the first run may have some issues, as the platelet gate may be incorrectly positioned compared to the second run on (b)(6) and a service visit was recommended.A review of historical records of the cell dyn sapphire, serial number (b)(6) , found that the field service engineer visited the customer site and performed the prevent maintenance module 3 (pm3) on the instrument.The instrument was performing within specification prior to being released to the customer.Return testing was not completed as returns were not available.Labeling was reviewed which adequately addresses the current issue.Based on the investigation no product deficiency was identified for the cell-dyn sapphire, sn (b)(6).

• 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: 9139756
• MDR Text Key: 184178537
• Report Number: 2919069-2019-00105
• 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: 10/14/2019

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: 08H00-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1