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

Catalog Number 06908217001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Hypoglycemia (1912)

Event Date 06/22/2018

Event Type  Injury  

Event Description

Customer reportedly received a reading which he did not question and dosed with insulin based on that reading.Customer reportedly tested again, time frame is unknown, and the result was either the same or similar resulting in customer dosing with insulin again based on the reading.Customer reportedly experienced a hypoglycemic episode that caused emts to be called and transport customer to the hospital; treatment received is unknown.Requested return of the alleged device for evaluation and replacement was provided.

• Brand Name: ACCU-CHEK ® AVIVA PLUS 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; na; indianapolis IN 46250 1025
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7686992
• MDR Text Key: 113951287
• Report Number: 3011393376-2018-02885
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 06908217001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• 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
• Treatment: INSULIN - TYPE UNKNOWN
• Patient Outcome(s): Required Intervention