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

Model Number 51493

Device Problem Expiration Date Error (2528)

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

Event Date 04/05/2019

Event Type  malfunction  

Event Description

Customer reported observation of "expired lot#" error when using statstrip glu test strips on (b)(6) 2019.Patient care was delayed as a result.

• 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: 8577747
• MDR Text Key: 148419808
• Report Number: 1219029-2019-00003
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2019
• Device Model Number: 51493
• Device Catalogue Number: 42214
• Device Lot Number: 0316278309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1