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

Model Number 42214

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Event Description

A user facility reported discrepant glucose results for a neonate patient.There was no patient harm reported.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Manufacturer narrative: the device history record (dhr) was reviewed, and no abnormalities or concerns were observed.The dhr indicated that the released product met all specifications.Nova biomedical had previously observed an increase in the number of complaints related to heelstick technique when testing blood glucose in neonates.As a result of this, comprehensive testing was performed on multiple strip lots simulating neonate patient usage, and determined that with proper sample collection and handling the system gives accurate results.A preventative action had been previously initiated to revise the labelling to add a precaution in regards to capillary heelstick sample collection.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• MDR Report Key: 9315005
• MDR Text Key: 201885380
• Report Number: 1219029-2019-00062
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42214
• Device Lot Number: 0318309249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1