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

Model Number 06908268001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

It was reported the patient received the following results within 15 minutes: 242 mg/dl, 248 mg/dl, 331 mg/dl using accu-chek aviva ii meter (serial number:(b)(4)) and 179 mg/dl using accu-chek aviva ii meter (serial number: (b)(4)).

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 16076713
• MDR Text Key: 308177173
• Report Number: 3011393376-2022-03832
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: 01/31/2024
• Device Model Number: 06908268001
• Device Catalogue Number: 06908268001
• Device Lot Number: 690342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: HUMALOG INSULIN; HUMULIN N INSULIN
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 108 KG