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

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Nova biomedical is awaiting additional information from the customer regarding the incidents.The customer returned the barcodes to nova for evaluation.Investigation ongoing.

Event Description

On (b)(6) 2019: nova statstrip hospital meter misread a barcode at 12:06 incorrectly.Barcode was for (b)(4) but meter read (b)(4).Another nova statstrip hospital meter also misread two barcodes at 8:08 and 9:34.

• 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: 8676540
• MDR Text Key: 148419703
• Report Number: 1219029-2019-00011
• 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: Non-Healthcare Professional
• 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: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1