MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 INTERNATIONAL VERSION; AUTOMATED PREANALYTICAL SYSTEM

Catalog Number 05082579001

Device Problem Device Handling Problem (3265)

Patient Problem Electric Shock (2554)

Event Date 03/28/2014

Event Type  Injury  

Manufacturer Narrative

Additional information has been provided by the customer.The customer did not consider her hand burned.There was only a red skin look.The customer was not treated with cream at the hospital.The customer only used her own "(b)(6)" cream by herself.The customer has returned to work.

Manufacturer Narrative

The system was not switched off when the customer attempted to grab the tube inside the system.Per the operator's manual, the system has to be switched off and the main voltage disconnected before working inside the device.

Event Description

The customer alleged a sample tube fell into the recapping module on their p612 device.The recapper cover had been removed before the tests were conducted.The customer accessed the tube by opening the twin tube assess door and putting her arm along the recapper device.The customer stated she could see it through the plexi cover.She grabbed the tube using a pair of pliers.On the way out, she received an electrical shock.The power source she had been in contact with was not identified.The customer was wearing nitrile gloves at the time of the incident.The main power source was not turned off at the time of the incident.The customer went to the emergency room for observations for six hours.The customer had an electrocardiogram performed and a "perfusion of serum phy." the customer received a cream to treat a hand burn.Additional details were requested but not provided.The customer was sent home as all was normal.The customer had not been trained on the device.There were warning labels on the twin tube access door.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: COBAS P 612 INTERNATIONAL VERSION
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3765976
• MDR Text Key: 11733158
• Report Number: 1823260-2014-02978
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/09/2014; 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other