MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. RAPIDLAB 1265; RL 1265

Catalog Number 10321852

Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/05/2014

Event Type  Other  

Manufacturer Narrative

Operator was instructed to refer to instrument operator's guide for instructions on how to properly flush the reagent manifold.Customer indicated that operator was checked within 24 hours after this incident and no bad situations have been found.He was checked for gtp, t-cho, tp, bun, ua, creat, clu, rpr, tpla, hbsag, hcv, hivag, hivab, htlv-1, and lv-1.He will be checked six times in total over the next year and will be monitored.This process is being followed in accordance with hospital policy.The event has occurred due to an operator error.

Event Description

Customer reported that blood splashed onto an operators eye, face and shoulder when he tried to remove clots from the reagent manifold.Customer indicated that operator washed his eyes per their site internal emergency procedure.There was no report of injury due to this event.

• Brand Name: RAPIDLAB 1265
• Type of Device: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3684012
• MDR Text Key: 18766826
• Report Number: 1217157-2014-00027
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1