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

Model Number	54790
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham, ma
• MDR Report Key: 9943278
• Report Number: 1219029-2020-00027
• Device Sequence Number: 11288048
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1