MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; PRE-ANALYTICAL TEST SYSTEM

Catalog Number 08166145001

Device Problem Mechanics Altered (2984)

Patient Problem Abrasion (1689)

Event Date 09/22/2022

Event Type  Injury  

Event Description

We received an allegation of an injury to a technician while they were removing a sample tube that was stuck in the tube type identification (tti) module of a cobas p612 pre-analytical system.The technician attempted to remove a tube from the gripper finger after an instrument alarm was generated (828).Product labeling for error 828 states: "message: 828 tti: failed to put tube back into ptt (tube transport).While the instrument was in standby mode, the technician went to the rear of the instrument, removed the tti cover, and attempted to remove the stuck sample tube.After removing the tube the gripper finger caught the technician's thumb causing a minor abrasion.Reportedly, a bandage was applied "on the spot." the technician underwent testing for hiv, hcv, hbv, liver, and kidney functions and is taking retrovirals for preventive measures.The results from the testing are not available at this time.The name of the drug was requested but was not provided.The technician will take the retroviral drug for 28 days.

Manufacturer Narrative

Occupation is company representative.The investigation found that the lifting-rotary gripper inside the tti module failed to re-insert a tube into the tube transport (ptt).When sorting the sample into the ptt holder, the bottom of the sample tube hit the edge of the ptt holder.As a result, the system generated the 828 error message.Product labeling for error 828 states: message: 828 tti: failed to put tube back into ptt (tube transport) description: lifting-rotary gripper inside tti module failed to re-insert tube into tube transport.Remedy: log out and shut the system down.Open tti housing, remove the.Affected tube and remount the housing again.Then reboot the system.Caution: always wear personal protective equipment when handling open tubes.The investigation determined that the gripper was in "work position" if the system is in work position, the system keeps the pressure on the gripper fingers to keep them closed around the tube.On the error pop-up window, one of which is "detail / solution" this button extends the message window and displays a list of corrective actions potentially suitable for rectifying the error.If the "solution" button is pressed, the following information would be displayed: "log out and shut the system down.Open the tti housing, remove the affected tube and remount the housing again.Then reboot the system." shutting down the system would release some of the pressure keeping the gripper fingers closed.The investigation determined that some of the sample tubes were not being handled properly at the customer site.There were some barcode labels that had not been applied to the sample tubes correctly: the barcode application is out of specification from the required 5-8mm distance of the label from the tube opening, cap, or plug.The barcode has not adhered around the sample tube properly and the label edges were sticking out.Product labeling states: "gap of 5-8 mm between label and tube opening, cap, or stopper cap" is the required "distance between label and tube opening, cap, or stopper cap." product labeling provides sample images of correct and incorrect barcode labels.One example of "incorrect" barcode label placement is "the label is sticking out." the technician did not follow the instructions given under the "solutions" button and went to the rear of the system, removed the tti cover, and attempted to release the sample tube when the gripper was in the "work position." the investigation determined the event was due to an operator handling issue.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: PRE-ANALYTICAL TEST SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15650942
• MDR Text Key: 302192140
• Report Number: 1823260-2022-03285
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• 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: 10/21/2022

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: 08166145001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/21/2022
• 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): Other