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

Catalog Number 04882458001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated the back of the accu-chek inform ii meter with serial number (b)(4) is discolored and appears burnt.The back of the meter is a brownish yellow color where the bottom silver charging contacts are located, around the top of the sticker where the serial number is printed.The customer thinks the meter overheated.The customer noticed the discoloration when the meter was brought to her office.There was no note left with the meter indicating what the initial issue was.The meter was being used and was working with the discoloration present.There were no other signs of burning on the meter.There were no signs of burning, smoking, flaming or melting on the associated base unit or power supply.Upon removing the battery from the meter, there were no signs of burning, bulging or damage to the battery or the compartment.No adverse event occurred.No one was injured.The meter was requested for investigation.

Manufacturer Narrative

The meter was returned.The charging function of the meter was tested with a retention inform ii base unit and a retention battery pack.A visual inspection was performed and discoloration was observed on the back of the returned meter.An optical investigation was made of the interior housing of the meter.There was no unusual heat produced during the charging process.No additional discoloration was observed after charging.A specific root cause was not identified for the discoloration on the back of the meter.This could have been caused from corrosion on the charging contacts caused by customer mishandling or contamination.

• Brand Name: ACCU-CHEK ® INFORM METER
• 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: 6653146
• MDR Text Key: 78096284
• Report Number: 1823260-2017-01282
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04882458001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• 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
• Patient Sequence Number: 1