MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 SL ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 02H31-01

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A followup report will be submitted when the evaluation is complete.Evaluation in process.

Event Description

The account stated the cell-dyn 3700 generated an error due to blood in the sample chamber.After an autoclean was performed a different operator decided to inject bleach using a syringe into a tube on the shear valve.While injecting the bleach a different tube came loose and bleach splashed in one eye of the operator.The operator was not wearing protective safety glasses.The operator washed her eye and received trobadex eye drop antibiotics (tobramycin, dexamethasone).The ophthalmologist confirmed that there was no eye lesions due to the bleach.The operator did not show any ill effects from receiving the tobradex antibiotic eye drops.

Manufacturer Narrative

The evaluation included review of product historical data and product labeling.The review of product historical data did not find a similar issue during the searched periods.The operator was not following the safety precautions stated in the cell-dyn 3700 operator's manual and should have been wearing a protective eyewear which may have prevented the liquid splash from getting into the eye area.Additionally, the cell-dyn 3700 operator's manual provides step by step procedures for unclogging the analyzer which were not followed.Because the operator did not wear protective eyewear and because the procedure used for unclogging the cell-dyn 3700 instrument was not followed, this event is determined to be a use error.The product labeling was reviewed and found to be adequate for this event.Based on the evaluation, the cell-dyn 3700 analyzer is performing acceptably.

• Brand Name: CELL-DYN 3700 SL 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: 5316951
• MDR Text Key: 34071221
• Report Number: 2919069-2015-00091
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K980614
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02H31-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2003
• 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
• Patient Outcome(s): Required Intervention