MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP BLLOOD GLUCOSE METER; STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Model Number 54790

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Complaint sample was not returned to nova and no serial or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The product catalog number was provided by nova's clinician for fda reporting purposes.Several attempts were made via phone and email; however, there has been no response.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to nova for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.No corrective action required based on the above evaluation.Trends will be monitored for this or similar complaints.

Event Description

Upon patient's arrival to emergency department (ed), the patient's blood glucose (bg) level was checked using glucometer.The blood glucose on glucometer read 47.Patient was treated with d50 per emergency dept provider, by primary rn 10 minutes later.A comprehensive metabolic panel collected immediately after blood glucose (bg) was checked with glucometer, resulted and showed glucose to be 75.To confirm, 2 hours later glucose confirmatory done within 5 minutes of blood glucose fingerstick to show glucose of 85.Glucometer showed 60 from fingerstick.

• Brand Name: BLLOOD GLUCOSE METER
• Type of Device: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham, ma
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect street; waltham, ma
• Manufacturer Contact: tracy turcotte ; 200 prospect street; waltahm, ma ; 6473700132
• MDR Report Key: 9943278
• MDR Text Key: 190818545
• Report Number: 1219029-2020-00027
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1