MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK® CONNECT APP; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number ASKU

Device Problem Incorrect Software Programming Calculations (1495)

Patient Problem Hypoglycemia (1912)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).While this product is not sold in the united states, it is like or similar to a product marketed in the united states.Device was not requested to be returned.

Event Description

Caller reported the accu-chek connect app advised an incorrect bolus amount.Caller stated she administered the advised bolus of 5 units of insulin at 8:55am and at 11:20am she experienced hypoglycemia; she was able to self-treat.No adverse event reported.No product was requested to be returned.

• Brand Name: ACCU-CHEK® CONNECT APP
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250 ; 3175212484
• MDR Report Key: 5051280
• MDR Text Key: 25491891
• Report Number: 3011393376-2015-03145
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 09/02/2015

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: ASKU
• Other Device ID Number: 00700009278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 039 YR
• Patient Weight: 70