MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II; HANDHELD POWER SUPPLY

Model Number HANDHELD POWER SUPPLY

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained that part of the plastic cover of the square block of the power supply (inlet block) attached to the accu-chek inform ii base unit was melted.The cable itself was not affected, only the power block.The customer was unable to determine what caused the plastic cover to melt or become damaged.The customer thought it could be from heat or from some kind of chemical that came into contact with it and caused the damage.There was no allegation that an adverse event occurred.The power supply was requested for investigation.

Manufacturer Narrative

Customer provided additional information that the cable was placed near a small desk lamp.

Manufacturer Narrative

The customer returned the power supply for investigation.Investigation found that there was no electrical fault in the power supply.The plastic lid was deformed inwards, meaning the heat was supplied from the outside.This was due to incorrect handling by the customer.Medwatch fields were updated.

• Brand Name: ACCU-CHEK INFORM II
• Type of Device: HANDHELD POWER SUPPLY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7490344
• MDR Text Key: 108101621
• Report Number: 1823260-2018-01398
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K071041
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HANDHELD POWER SUPPLY
• Device Catalogue Number: 05388805001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 04/17/2018
• Supplement Dates FDA Received: 06/15/2018; 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1