MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SMS; AUTOMATED BLOOD FILM PREPARATION AND STAINING

Catalog Number 05H29-04

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

The customer reports that a blood film prepared by the cell-dyn sms (ln: 05h29-04) was made from the blood of two different patients.A slide prepared from sample 15p021188 contained many blast cells and was prepared at 13:38.The next slide (sample 15p021147) contained blast cells and prepared at 13:49, which did not fit the patient's clinical condition.At the time, the instrument was generating internal waste full recovery errors, although the collector bottle was not full.The customer believes that the suspect film was due to carryover caused by this error.The customer manually prepared a new slide from sample 15p021147, which did not contain any blast cells.An abbott field service engineer at the site could not recreate the issue.No suspect results were reported from the lab with no patient impact.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Date of event and date of report and date received by the manufacturer are due to time zone differences.

Manufacturer Narrative

No returns were made available from the customer site for this evaluation.An abbott field service engineer (fse) evaluated the instrument at the customer site.The fse performed a full check and cleaning on the internal waste chamber.All subsequent instrument operations and test results were acceptable.The customer's issue could not be recreated.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The cell-dyn sms system operator manual contains information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence of a product deficiency.The issue was addressed through standard troubleshooting procedures.

• Brand Name: CELL-DYN SMS
• Type of Device: AUTOMATED BLOOD FILM PREPARATION AND STAINING
• 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: 4711308
• MDR Text Key: 5743787
• Report Number: 2919069-2015-00020
• Device Sequence Number: 1
• Product Code: GKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05H29-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WASTE RESERVOIR LN: 8921174802