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

Catalog Number 04882300001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2017

Event Type  malfunction  

Event Description

The customer initially complained that the accu-chek inform ii base unit was not charging.The light will come on to show it has power.During troubleshooting, the customer noticed burn marks on the base of the device near the led light.The customer stated it looked like smoke.There were no other signs of melting or flaming.There were no signs of melting, smoking, burning or exploding on the associated power supply or accu-chek inform ii meter.There was no allegation that an adverse event occurred.The inform ii base unit was requested for investigation.

Manufacturer Narrative

A specific root cause could not be determined for this event.The customer has not returned the base unit.No information was provided in the complaint that would point to a cause for the burn marks or the charging issue.Since the product was not returned, the investigation could not be completed.

Manufacturer Narrative

The customer returned the base unit.The markings near the led light the customer referred to were observed during investigation.The charging function was checked and the interior of the base housing was investigated.A retention meter was charged using the customer's base unit.No smoke was produced and no extra markings were reproduced.There was no unusual warming up during the charging process.The device was lukewarm which couldn't lead to redness or burning of skin.The "burn" markings were easily wiped off using proper cleaning procedure.The "burn" marks seem to have been caused by writing utensils.A product problem was not identified.

• 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: 6503387
• MDR Text Key: 73124573
• Report Number: 1823260-2017-00817
• 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,Followup
• Report Date: 08/13/2017

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 Catalogue Number: 04882300001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided; 03/24/2017
• Supplement Dates FDA Received: 05/11/2017; 08/13/2017
• 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