MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 671 CENTRIFUGE UNIT; SPECIMEN PROCESSING INSTRUMENT IVD, AUTOMATED

Catalog Number 07563795001

Device Problem Fail-Safe Problem (2936)

Patient Problem Skin Erosion (2075)

Event Date 05/06/2022

Event Type  Injury  

Event Description

We received an allegation that a roche service representative (rsr) was injured while performing service on a cobas p671 centrifuge unit.The rsr reportedly bridged the safety lock from the protective door, pressed "standby" and leaned over with his head in the area where the robot arm was moving.The robot arm with the gripper hit his head.The gripper allegedly hit and "crashed" the rsr¿s glasses.The broken pieces from his glasses scratched his face causing a 2 cm wound.The rsr sought medical treatment and the doctor reportedly sutured the wounds and administered a tetanus shot.The rsr is allegedly applying "ointments" to the wound twice a day.The doctor reportedly told the rsr it would take 3-6 months to heal completely.As of (b)(6) 2022 the rsr is reportedly feeling good and is back at work.

Manufacturer Narrative

Occupation is roche senior service engineer.When a safety door is bridged, the instrument "thinks" the protective door is closed and the robot arm moves as it does during normal operation.Because the instrument was running in routine, the rsr pressed "standby" to pause the instrument.When "standby" is pressed, the instrument¿s robot arm finishes the current task and then moves to the home position.The rsr thought the robot arm stopped instantly.The rsr should have waited for the robot arm to reach the home position followed by the sound of unlocking the actuator that locks the door.The investigation concluded that the event occurred because of an operator error not following the instructions given during the previous trainings.Bridging the safety lock to perform service activities is normal and is taught during service training.The rsr in this case was trained on this instrument in 2018.When the standby button is pressed, there is a visible check that the sorting arm moves to the standby position, the system generates subsequently a clicking noise and the red and yellow lights of the signal tower are lit steadily.In addition, information and warnings about the moving parts can be found in the documentation and the instrument itself.Product labeling states: "pressing the [standby] button completes the current work step, moves the sorter unit to its standby position and then halts the system.In order to resume the work cycle, press the [run] button." and "do not reach into the storage area or the operating range of the gripper unless in standby mode!".

Manufacturer Narrative

Codes were updated.

• Brand Name: COBAS P 671 CENTRIFUGE UNIT
• Type of Device: SPECIMEN PROCESSING INSTRUMENT IVD, AUTOMATED
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14594472
• MDR Text Key: 293284041
• Report Number: 1823260-2022-01587
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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: 07563795001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/28/2022
• 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): Required Intervention
• Patient Sex: Male