MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 1800 ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 07H77-01

Device Problem Incorrect Or Inadequate Test Results (2456)

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.An evaluation is in process.

Event Description

The customer observed discrepant hemoglobin (hgb) results while using the cell-dyn 1800 analyzer.The following data was provided.Initial 7.4, repeat 8.6 g/dl no impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, an instrument service review, and labeling review.No adverse trend was identified for the customer issue.Service history review identified no contributing factors to the customer issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Describe event or problem, update information.An evaluation is in process.

Event Description

The customer provided a previous hemoglobin result (10.0 g/dl) for the patient, however the specific test date was not provided.

• Brand Name: CELL-DYN 1800 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: 7143853
• MDR Text Key: 96121304
• Report Number: 2919069-2017-00170
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740071141
• UDI-Public: 00380740071141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07H77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2005
• 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