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

Model Number 1.86

Device Problem Complete Loss of Power (4015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Event Description

Nova biomedical (nova) was made aware of a potential issue regarding the loss of power while using a statstrip glucose meter with the serial number (b)(4).It was reported the loss in power caused the healthcare provider to draw a sample from the pediatric patient a second time, something which would not have been necessary had the meter not lost power.No other delays in treatment were reported.

Manufacturer Narrative

There is currently a pending investigation.Nova biomedical is requesting additional information, and further details will be provided in a supplemental report.

Manufacturer Narrative

There is currently a pending investigation.Nova biomedical is requesting additional information, and further details will be provided in a supplemental report.

Manufacturer Narrative

The customer reported a power issue was observed while using a nova biomedical statstrip glucose meter with sn (b)(6).The device lost power after drawing a sample from a pediatric patient.Due to the power loss, it was necessary to draw an additional sample from the patient in order to measure the glucose values.This occurred on (b)(6) 2021.No additional delays in treatment were reported.The meter and battery were not returned to nova biomedical for investigation.However, the customer did return a different meter exhibiting similar problems.This meter was tested using batteries retained by the manufacturer, performing a drop test from a height of one foot and a bounce test which including lifting the bottom of the meter from a surface and dropping it down, allowing it to bounce.After performing these tests, the reported problem could not be reproduced.Device history record (dhr) reviews were performed for the meter being used at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter and test strips.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be confirmed after testing the returned customer meter.A root cause was unable to be identified.While the reported issue was not reproduced on the returned meter, nova biomedical is working on improvements to the meter's battery housing.A new, slightly elongated design has already undergone initial testing and qualification and further testing is being completed.Nova will continue to monitor for recurrence of similar events.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 12674384
• MDR Text Key: 277723953
• Report Number: 1219029-2021-00042
• Device Sequence Number: 1
• Product Code: PZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.86
• Device Catalogue Number: 54794
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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