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

Catalog Number MPH 4540

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

Patient Problem Hyperglycemia (1905)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

No.275 blood glucose obtained using evencare proview glucometer results 407.Subsequent glucose 136.Evencare proview glucose monitor (b)(4).Evencare proview test strips gtin (b)(4), exp (17): 04/19/2019, lot (10): ar020z1a1.Evencare proview glucose control solutions: gtin (b)(4), exp(17): 02/03/2019, lot(10): 6b02a047b03b04, ref (b)(4).

• Brand Name: EVENCARE PROVIEW BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: GLUCOMETER AND TEST STRIPS
• Manufacturer (Section D): MEDLINE INDUSTRIES; mundelein IL
• MDR Report Key: 7049311
• MDR Text Key: 92794051
• Report Number: MW5073478
• 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: MPH 4540
• Device Lot Number: AR02071A1
• 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
• Patient Age: 68 YR
• Patient Weight: 166