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 Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.(b)(4).

Event Description

The customer observed a falsely depressed hemoglobin result on the cell-dyn sapphire analyzer.The following data was provided: initial 5.7, repeat 13.4 (flagged) g/dl.The patient had a previous result of 13 g/dl.The results were not released from the lab and there was no impact to patient management.

Manufacturer Narrative

Additional discrepant data was provided via fax on 12/24/2015: (b)(6) initial hemoglobin 5.72, repeat 13.4 g/dl.Initial hematocrit 20.8, repeat 39.6%.There was no impact to patient management reported.An investigation is still ongoing, and a final report will be sent when the investigation is complete.

Event Description

(b)(6) initial hemoglobin 5.72, repeat 13.4 g/dl.Initial hematocrit 20.8, repeat 39.6%.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Field service replaced the following parts: peristaltic pump tubing, aspiration needle, vent head assembly, and fitting connector which resolved the issue.Based on all available information and abbott diagnostics' complaint investigation no product deficiency 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
• 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: 5333506
• MDR Text Key: 35076939
• Report Number: 2919069-2015-00093
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1