MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; METER,GLUCOSE,EVENCARE PROVIEW,PROF.USE

Model Number MPH4540

Device Problem Inaccurate Information (4051)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/10/2023

Event Type  Injury  

Event Description

According to the customer, the patient came in with a blood glucose in the "400's".The customer reported an infusion was started and "2.5 hours" into the infusion the blood glucose was "still high" but when checked using a different monitor the blood glucose "was at 47.".

Manufacturer Narrative

According to the customer, the patient came in with a blood glucose in the "400's." the customer reported an infusion was started and "2.5 hours" into the infusion the blood glucose was "still high" but when checked using a different monitor the blood glucose "was at 47." the customer reported the blood glucose monitors were checked and all of them were off by "20-40 from each other." the customer reported the patient "recovered with no complications".No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Type of Device: METER,GLUCOSE,EVENCARE PROVIEW,PROF.USE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17239152
• MDR Text Key: 318223136
• Report Number: 1417592-2023-00270
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10888277409163
• UDI-Public: 10888277409163
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MPH4540
• Device Catalogue Number: MPH4540
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other