MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® NANO; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 05423066001

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent a report to the fda.

Event Description

Caller alleges the meter shows signs of melting, burning and smells like smoke.Caller reported that one of the batteries in the meter looks burnt.No adverse event reported.Requested return of the alleged device for evaluation and replacement was sent.

Manufacturer Narrative

The investigation of the returned meter determined that there were no signs of melting/burning/smoking with the product.However, the meter would not power on due to corrosion of the internal components caused by liquid contamination.

• Brand Name: ACCU-CHEK ® NANO
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; rathealy road; na; fermoy 00000 ; EI 00000
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 6868954
• MDR Text Key: 86314466
• Report Number: 3011393376-2017-05155
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05423066001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 102