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

Lot Number 452110

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

While this product is not sold in the united states, it is like or similar to a product marketed in the united states.This event occurred in (b)(6).

Event Description

Reporter stated that patient received the following results on advantage/sensor system compared to a professional meter within 10 minutes: 483 mg/dl (advantage/sensor system) and 113 mg/dl (professional meter).No adverse event was reported.The customer could not provide any information regarding the test strips.The alleged product is not available to return for evaluation.

• Brand Name: ACCU-CHEK ® ADVANTAGE 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 PUERTO RICO; 2875 ponce by-pass; 2875 ponce by-pass; ponce PR 00728 2801
• Manufacturer Contact: greg smith ; 9115 hague road; 9115 hague road; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 5342283
• MDR Text Key: 35301692
• Report Number: 3011393376-2016-00006
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 452110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/07/2015
• 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 Age: 69 YR