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

Catalog Number 05H29-01

Device Problem Device Operates Differently Than Expected (2913)

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 reports that the cell-dyn slide maker stainer (sms) instrument assigned the incorrect patient identification to a prepared blood sample film.The issue could not be recreated.There is no impact to patient management reported.

Manufacturer Narrative

Instrument log files from the cell-dyn sms (slide maker stainer) were not available from the customer site.From information gathered from the customer, the instrument experienced an issue in its dispensing/rinsing circuit causing some blood from the first sample to remain in the aspiration tubing.It is reasoned that a small amount of air was blocking the tubing and a portion of the first sample remained in the tubing and was not dispensed onto the first slide.The remaining blood was diluted with diluent during the rinsing process.This caused the next sample aspiration to be negatively affected because the sensor detected the presence of the remaining sample in the aspiration circuit.When the dispense cycle for the second sample was performed, the diluted first sample was added to the second slide.The customer could not tell if the blood smear of the second slide is a mixture of the first and second samples.The results of the review of the second slide were not provided.A positive identification could not be determined.An abbott field service engineer (fse) visited the customer site and could not reproduce the issue.However, as a preventive measure, several instrument parts were either cleaned or replaced.Subsequent instrument operations were acceptable.No further issues were noted.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 operation manual contains information to address the current customer issue.This issue was specific to the individual cell-dyn sms instrument at this specific customer site.Based on the evaluation results and the information from the customer site, there is no evidence to reasonably suggest a product deficiency is present.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: 5749171
• MDR Text Key: 48192286
• Report Number: 2919069-2016-00768
• Device Sequence Number: 1
• Product Code: GKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05H29-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2000
• 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