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

Model Number 1.75

Device Problem Patient Data Problem (3197)

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

Event Date 04/09/2022

Event Type  malfunction  

Manufacturer Narrative

There is currently a pending investigation.The customer is unsure of the exact meter but has narrowed it down to four possible serial numbers.Those serial numbers are (b)(4).Nova is requesting additional information and further details will be provided in a supplemental report.

Event Description

The customer reports that a statstrip meter scanned a patient armband incorrectly.When one patient was scanned, a different patient's data appeared.After a rescan, the correct patient's information appeared so the responsible meter's serial number was not taken note of.There was no patient harm or intervention reported.

Manufacturer Narrative

The customer provided samples of the armbands that are used at their facility.The armbands/barcodes were graded at nova by a validated scanner and the barcodes graded poorly.It was recommended to the customer to improve their barcode printing.Dhr reviews were performed on the four meters that the customer suspected and there were no abnormalities observed.

• Brand Name: NOVA STATSTRIP HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13505963
• MDR Text Key: 286599341
• Report Number: 1219029-2022-00008
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.75
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• 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