MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® POCKET COMPASS; DIABETES MANAGEMENT SOFTWARE

Lot Number ASKU

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Hypoglycemia (1912)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Company representative reported the customer received inaccurate bolus advice from the pocket compass software, which resulted in a hypoglycemic event.The customer received a blood glucose result of 82 mg/dl at 8:34 p.M., and the pocket compass software recommended a bolus of 10.0 units of insulin for 19 grams of carbohydrates.She felt this was too high and programmed a bolus of 5.0 units instead.At 1:30 a.M., her husband woke and found her unconscious and in a coma.He called 911, and when the paramedics arrived, her blood glucose was 23 mg/dl on the professional device.She was treated with glucose solution via iv and transported to the hospital.She remained at the hospital for 4 hours and was then released.It was confirmed the settings are programmed correctly.Three attempts were made to reach the customer, but these were not successful.No product will be returned for evaluation.

Manufacturer Narrative

This correction is being sent to document that the code aneurysm was sent by mistake.

• Brand Name: ACCU-CHEK ® POCKET COMPASS
• Type of Device: DIABETES MANAGEMENT SOFTWARE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; sandhoferstrasse 116; mannheim 68305 ; GM 68305
• Manufacturer Contact: greg smith ; 9115 hague road; 9115 hague road; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 5448822
• MDR Text Key: 38629221
• Report Number: 3011393376-2016-01390
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: 02/02/2016
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82