MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK AVIVA PLUS; GLUCOSE DEHYDROGENASE, GLUCOSE

Catalog Number 06908217001

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2019

Event Type  malfunction  

Event Description

Glucose strip did not work when the blood from a finger stick was applied to it.When blood drop is touched to the edge of the strip, the blood normally moves up about one eighth of an inch on the strip.This did not happen with this lot of test strips: roche accu-chek plus, lot #498315, cat #06908217001.Fda safety report id# (b)(4).

• Brand Name: ACCU-CHEK AVIVA PLUS
• Type of Device: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.
• MDR Report Key: 9335067
• MDR Text Key: 166948632
• Report Number: MW5091131
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 06908217001
• Device Lot Number: 498315
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 77