MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA ANALYZER

Catalog Number 10282970

Device Problems Device Reprocessing Problem (1091); Contamination (1120); Sticking (1597); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problems Exposure to Body Fluids (1745); Injury (2348)

Event Date 10/08/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Operator should not have used forceps to remove the cartridge and should have followed instruction given in the operator's manual.As per dca operator's manual, "when handling the reagent cartridge, do not force the removal of the cartridge.This can cause physical injury to you and damage to the analyzer." customer indicated that operator attended a medical clinic where the wound was swabbed with alcohol and covered with a band aid and blood was taken to establish a baseline (b)(6).Customer is not prepared to provide any additional personal information.

Event Description

Customer reported that dca operator wounded herself with contaminated forceps while attempting to remove stuck cartridge.Customer found that operator had not removed test cartridge after finishing test.Cartridge was left in instrument for two weeks and it was stuck inside the instrument.Customer attempted to remove the cartridge with forceps and the top of the cartridge became damaged as the forceps penetrated the top.The customer then accidentally wounded herself with the forceps on the hand.

• Brand Name: DCA ANALYZER
• Type of Device: DCA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5195293
• MDR Text Key: 30474025
• Report Number: 1217157-2015-00153
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10282970
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1