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

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Nova biomedical is awaiting additional information from the customer regarding the incident and has requested the barcodes for evaluation.Investigation ongoing.

Event Description

Nova statstrip hospital meter patient barcode mis-scan.Operator scanned chart sticker and it displayed as a different, but valid, patient id.The wrong patient name was displayed on the meter and was accepted by the operator.This caused the result to be sent to the wrong patients chart.No patient impact as a result of the mis-scan.

• 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 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02454-3465 ; 7816473700
• MDR Report Key: 8676539
• MDR Text Key: 147343690
• Report Number: 1219029-2019-00010
• Device Sequence Number: 1
• Product Code: PZI
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1