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

Model Number 54790

Device Problem Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

The customer returned the statstrip wireless meter serial number (b)(4).The meter along with the patient's wristband were returned to nova on (b)(6) 2021.An investigation is currently underway based on the information and material provided and a device history record (dhr) review has been requested.A supplemental report will be submitted upon completion.

Event Description

Customer reported to nova biomedical on (b)(6) 2021 that a bar code scan mis-read occurred on a statstrip wireless meter serial number (b)(4) while scanning a patient wristband's information.On (b)(6) 2020 the reported mis-read was discovered when the customer tried to find a glucose result in their his/lis network but could not find it.They reviewed the meter and found that the bar code in memory did not match the bar code that was scanned.No patient impact or adverse event reported.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02454 9141
• Manufacturer Contact: lee perloff ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 11273300
• MDR Text Key: 231309996
• Report Number: 0001219029-2021-00001
• Device Sequence Number: 1
• Product Code: PZI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1