MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® INFORM BASE; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 05060290001

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The unit was requested for investigation and a replacement product was sent to the user.

Event Description

The initial reporter stated there was an issue with the accu-chek inform ii base unit.The user reported that the base unit was not charging meters and downloading devices.He also noted that the base unit had damaged contacts.The user confirmed that the base unit contacts were damaged.He also noted seeing smoke from the base unit while it was connected to the power unit.There was no report of burns or serious injury.

Manufacturer Narrative

The base unit was returned for investigation.The base unit would not power on.Base unit was opened and examined.No contamination was found internally.Evidence of a charred integrated circuit was found inside the base unit on the circuit board.The investigation of the base unit is still ongoing.Medwatch fields d9 and h3 have been updated.

Manufacturer Narrative

The device was disassembled for investigation.During visual inspection, it was confirmed that an electronic building block got hot.After starting up the base, it could be successfully connected to the computer via a universal serial bus (usb) drive and there were no issues noted in the electronic building block.The outer contacts of the local area network (lan) socket were slightly bent.The connection via lan could not be established.Data transformer on the printed circuit board (transformer for galvanic isolation of the ethernet interface) showed traces of smoldering and was noted to be damaged.There was no evidence of fire.The investigation concluded that the damage was caused by improper use.

• Brand Name: ACCU-CHEK ® INFORM BASE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• 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: 12639978
• MDR Text Key: 276651776
• Report Number: 1823260-2021-03012
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05060290001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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