MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100; AUTOMATED PREANALYTICAL SYSTEM

Model Number 8100

Device Problem Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

During the maintenance action of cleaning the operator moved her hand into the waste chute to clean the inside using forceps.The operator did not wear protective gloves as stated in the operator's manual.The investigation is ongoing.

Event Description

An operator received a 1/2 inch cut on her right thumb while cleaning the inside of the aliqouter module (aqm) waste chute during maintenance.The cut was a deep scratch/cut that broke skin of cuticle area down to the thumb nail.The operator went to the emergency room and received a bandage and a 28 day hiv prophylaxis regimen.During the maintenance action of cleaning, she moved her hand into the waste chute to clean the inside.Product labeling indicates that forceps are required to clean the waste chute.During the maintenance action of cleaning, she moved her hand into the waste chute to clean the inside.Product labeling states: "use lint-free cloth moistened with alcohol and held with forceps to wipe the inside and outside of the waste chute cover." product labeling also warns about potential personal injury and infection due to sharps, rough edges, and/or moving parts and that suitable lab gloves, eye protection, lab coat, and footwear should be worn.The operator was not wearing gloves.

Manufacturer Narrative

The investigation found that the operator was not following the instruction provided in the operator's manual regarding personal precaution when working.The investigation did not identify a product quality problem.

Manufacturer Narrative

Section b2 updated.

• Brand Name: COBAS 8100
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10785646
• MDR Text Key: 215956068
• Report Number: 1823260-2020-02775
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

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: 8100
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 10/05/2020
• Supplement Dates FDA Received: 11/25/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other