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

Catalog Number 02H31-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Injury  

Event Description

The customer stated that the warehouse housekeeper accidentally hit his head on the cell-dyn 3700 when he was trying to clean the repair center.The wound started to bleed, so the employee went to emergency services.The wound was cleaned, received 5 stitches, and bandaged.The employee was not given any vaccination as he had received the (b)(6) vaccination 15 days prior to the incident.The instrument that he hit his head on was decontaminated by the field service engineer before the accident happened.This is considered an adverse event for serious injury as stitches were required.There was no additional patient information provided.

Manufacturer Narrative

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

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, a review for similar complaints, and a review of labeling.A warehouse cleaning personnel was injured while cleaning the repair center in which the cell-dyn 3700 was located.The instrument was in the process of being repaired and the incident was not related to an instrument failure as it was not in operation at the time.A review of complaints for the cd3700, serial number (b)(4), did not identify any product issue.A review of product labeling shows adequate precautionary warnings and information necessary to ensure safety and the safe use of the cell-dyn 3700 system.Based on the investigation there was no product deficiency or malfunction identified for cell-dyn 3700, list number 02h31-01, serial number (b)(4).

• 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 ; 847937-512
• MDR Report Key: 3957625
• MDR Text Key: 4556099
• Report Number: 2919069-2014-00041
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K980614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 02H31-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention