MAUDE Adverse Event Report: MEDLINE INDUSTRIES EVENCARE PROVIEW SYSTEM; GLUCOMETER AND TEST STRIPS

Catalog Number MPH4540

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Control test performed on meter.Test level 2 - 84.Test level 3 - 321.Repeat test level 3 - 288.On (b)(6) 2017 control test level 3 - 321.Out of range.Evencare proview glucose monitor: (b)(4).Evencare proview test strips: gtin (b)(4), exp (17): 04/19/2019, lot (10): ar20z1a1.Evencare glucose control solutions: gtin (b)(4), exp (17): 02/03/2019, lot (10): 6302a047b0304, ref: (b)(4).

• Brand Name: EVENCARE PROVIEW SYSTEM
• Type of Device: GLUCOMETER AND TEST STRIPS
• Manufacturer (Section D): MEDLINE INDUSTRIES; mundelein IL
• MDR Report Key: 7049016
• MDR Text Key: 92837252
• Report Number: MW5073463
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Catalogue Number: MPH4540
• Device Lot Number: AK020Z1A1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1