MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® POCKET COMPASS; DIABETES MANAGEMENT SOFTWARE

Catalog Number 04658051160

Device Problem Incorrect Software Programming Calculations (1495)

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

Event Date 08/29/2014

Event Type  malfunction  

Event Description

Patient questioned the bolus advice on her palm centro bolus calculator.Patient reported she calculated a carbohydrate of 15 grams and the bolus calculator advised a bolus of 0.8 units.Patient stated her carbohydrate ratio is 1 unit for 15 grams of carbohydrates.No adverse event reported.Product was replaced and requested return of the bolus calculator and pump.

Manufacturer Narrative

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

Manufacturer Narrative

It was unknown if the initial reporter sent a report to the fda.The product involved in the complaint was not returned.

• Brand Name: ACCU-CHEK ® POCKET COMPASS
• Type of Device: DIABETES MANAGEMENT SOFTWARE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4117910
• MDR Text Key: 4840083
• Report Number: 1823260-2014-07311
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

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: Lay User/Patient
• Device Catalogue Number: 04658051160
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• 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