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

Catalog Number 10321852

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

Customer reported that they accidentally installed glucose sensor in the lactate sensor position in a rl1265 on (b)(6) 2015 at 10am.Customer indicated that quality control and calibration were ok.Customer indicated that patient results for lactate obtained all day with a glucose sensor and results were slightly higher (about 2-3 g/dl).There was no report of injury due to this event.

Manufacturer Narrative

Siemens review data from customer's 1265 system.Siemens technical operation team reviewed glucose and lactate nanoamp outputs to see how they compare.Investigation result: installing a glucose sensor in the lactate channel or vice versa may or may not trip d3-codes depending on the sensor slope.Qc levels 1 and 3 will fail.Level 2 could be within range and pass.Conclusion: 1200 series manual instructs the operator to run 2 different levels of qc material after maintenance is performed.The human error would have been detected if this was done.The issue occurred due to an operator error.Instrument is performing as intended.

• Brand Name: RAPIDLAB 1265
• Type of Device: RL 1265
• 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: 4902083
• MDR Text Key: 21767008
• Report Number: 1217157-2015-00092
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K031560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10321852
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1