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

Model Number 53398

Device Problem Erratic Results (4059)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint sample has not returned to nova as of yet; therefore, an evaluation of the device could not be performed.Further investigation is being completed and a supplemental report will be submitted upon completion.

Event Description

The customer reported discrepant patient results.A test was run on (b)(6) on the statstrip 1.75 meter sn: (b)(4) and a flow error occurred.It was rerun and was less than 10, a draw was done and it was 532.The patient was moved to another floor and tested with another meter and received good results.There was no patient harm or medical intervention.

• Brand Name: STATSTRIP GLUCOSE 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 st; waltham MA 02454
• Manufacturer Contact: jesus matos ; 200 prospect st; waltham, MA 02454 ; 7816473700
• MDR Report Key: 11809037
• MDR Text Key: 267895545
• Report Number: 1219029-2021-00020
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53398
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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