MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; STRIP,GLUCOSE,EVENCARE PRO

Model Number	MPH4550
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 a residents blood sugar was being checked per policy and protocol and the staff member noted, 'the number appeared higher than usual'.The staff member rechecked the blood sugar and still received a 'high number' and gave the resident sliding scale insulin.Per the facility they purchased a different monitor and strips and retested the resident as they still believed the number was inaccurately high.Upon retesting the resident that number was, 'very low' and the patient was sent to the hospital.Per the facility the patient is reporting to be doing fine.The facility also stated that the monitor is routinely tested prior to use on patients and they have not had any further issues since switching devices.The sample was returned for evaluation and a definitive root cause could not be determined as all strips read within their specified parameter.No additional information is available or provided at this time.Due to the reported incident and 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.
Event or Problem Description
According to the facility on (b)(6) 2022 a residents blood sugar was being checked per policy and protocol and the staff member noted, 'the number appeared higher than usual'.The staff member rechecked the blood sugar and still received a 'high number' and gave the resident sliding scale insulin.

• Brand Name: Medline
• Common Device Name: STRIP,GLUCOSE,EVENCARE PRO
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15710052
• Report Number: 1417592-2022-00208
• Device Sequence Number: 17797142
• Product Code: CGA
• UDI-Device Identifier: 10888277409170
• UDI-Public: 10888277409170
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MPH4550
• Device Catalogue Number: MPH4550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown