MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® SMARTVIEW TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number 06337538001

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reportedly received the following results within 10 minutes: 310 mg/dl, 147 mg/dl, 275 mg/dl, 172 mg/dl, and 216 mg/dl.No adverse event reported.Return of suspect device was requested and replacement was sent.

• Brand Name: ACCU-CHEK ® SMARTVIEW TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; 9115 hague road; indianapolis IN 46250 1025
• Manufacturer Contact: greg smith ; 9115 hague road; 9115 hague road; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 5480820
• MDR Text Key: 39695709
• Report Number: 3011393376-2016-01541
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 06337538001
• Device Lot Number: 474256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided; 02/12/2016
• Supplement Dates FDA Received: 05/05/2016; 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 75