MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

Model Number DIMENSION EXL WITH LM

Device Problem Leak/Splash (1354)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and request for assistance with replacing a bent sample probe tip that was stuck in a sample tube.The customer indicated that an operator was exposed to patient sample when she was troubleshooting this issue.The tip was bent because the customer inadvertently mis-programmed the sample.A siemens specialist assisted the customer in replacing the probe tip and requested the customer to run a system check and quality controls.The customer reported that the instrument is processing without errors.The operator was not wearing safety goggles when troubleshooting the instrument.The cause of event is attributable to the operator's method in troubleshooting the bent sample probe tip.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that patient's sample splashed into an operator's eye as she replaced a bent probe on a dimension exl with lm instrument.The operator was not wearing goggles and the operator contacted the hospital's health provider, who recommended the operator to rinse her eyes.No further medical intervention was required.There are no known reports adverse health consequences due to the event.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2020-00240 on 13-aug-2020.Additional information (17-aug-2020): no sample/blood was reported to have dropped onto the instrument.The original sample involved with the bent sample probe was repeated and the results were considered acceptable after the probe replacement with no redraw required.No other patient samples were affected by this incident.The customer successfully ran system check and quality controls, and the instrument was fully functional upon the completion of the sample probe replacement.Siemens further investigated this incident and determined that the cause of the customer's exposure to patient's sample during troubleshooting was due to the customer not wearing proper personal protection equipment (ppe) while removing the bent sample probe as instructed by the dimension exl with lm/dimension exl 200 operator's guide.Under the biohazard and probe safety heading, the dimension exl with lm / dimension exl 200 integrate chemistry system operator's guide indicates: "the sample probe is a biohazard.Follow laboratory safe protection biohazard procedures when performing maintenance and troubleshooting procedures." the instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10401367
• MDR Text Key: 202951819
• Report Number: 2517506-2020-00240
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR