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

Model Number	42214
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• MDR Report Key: 9315005
• Report Number: 1219029-2019-00062
• Device Sequence Number: 1950897
• Product Code: PZI
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 42214
• Device Lot Number: 0318309249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1