MAUDE Adverse Event Report: PARATA ROBOTIC DISPENSING MACHINE

Device Problems Device Operates Differently Than Expected (2913); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

(b)(4).A patient returned to the pharmacy with a prescription bottle filled with the correct medication filled by the parata robot, but labeled over with an incorrect patients label for a different medication.It was verified that the bottle contained the generic floricet tablets in the bottle and a correct label was reprinted and fixed to dispense back to the patient.Medication administered to or used by the patient: yes.When and how was error discovered: a patient returned to the pharmacy with a prescription bottle filled with the correct medication filled by the parata robot, but labeled over with an incorrect patientlabel for a different medication.Level of staff who discovered the error: consumer/family member/caregiver.Patient counseling provided: unk.(b)(6).

• Brand Name: PARATA ROBOTIC DISPENSING MACHINE
• Type of Device: PARATA ROBOTIC DISPENSING MACHINE
• MDR Report Key: 6066836
• MDR Text Key: 59455313
• Report Number: MW5065696
• Device Sequence Number: 1
• Product Code: NEP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FIORICET - TABLET, ORAL.