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

Model Number P 612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The user was loading racks on the instrument output buffer and cut his finger on a rack tray.He was training on the instrument at the time.He washed his finger thoroughly and placed a bandage on it.He wrapped up his finger and placed a glove over it.The user was wearing a laboratory coat and nitrile powder fee exam gloves at the time of the event.The user stated that the rack tray was not damaged and is fairly new.The user went to an immediate care center on (b)(6) 2016 and he did not require stitches.He received post exposure treatment and received a (b)(6) booster.He was also treated with a tetanus shot.The user's blood was collected for infectious disease tests and he is to return for further testing on (b)(6) 2016, in 3 months, in 6 months, and in 12 months.The user states that the cut is now healed and that he feels fine.He considers himself healthy and has no complaints.Mandatory updated cleaning instructions have been provided to all current customers as well as future customers.The update of the cleaning procedure contains proper instructions and warnings not to touch the edges of rack trays and includes instructions for safe handling of the parts to avoid the risk of injury.

Manufacturer Narrative

The user has clarified that he was removing racks from the output unit to make room for more racks.He was pushing the racks off close to the base of the rack when his finger was snagged on the center rail flange of the rack tray.The user stated that racks would bind up and not slide off if he pushed the racks near the top.The account still uses the tray.The user bandaged his finger and cleaned the tray.The customer kept working.Investigations conclude that the accident is considered to be an abnormal use of the rack tray.The rack tray was requested for investigation, but the customer could not differentiate the rack tray involved in the event from others in the laboratory.

Manufacturer Narrative

The following information was provided previously: "the user has clarified that he was removing racks from the output unit to make room for more racks.He was pushing the racks off close to the base of the rack when his finger was snagged on the center rail flange of the rack tray." it has been clarified that the racks were picked up by the handles when removed from the output unit and manually moved to a cart.

Manufacturer Narrative

The root cause for the issue could not be clearly identify because customer could not isolate the affected tray and provide it for investigation.No product problem could identified.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6085362
• MDR Text Key: 59398085
• Report Number: 1823260-2016-01744
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2017

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 Model Number: P 612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/29/2016; 02/06/2017; 04/25/2017
• 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
• Type of Device Usage: N
• Removal/Correction Number: RES 75186
• Patient Sequence Number: 1
• Treatment: NO MEDICATION
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR