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

Model Number 54790

Device Problem Overheating of Device (1437)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Udi- (b)(4).The customer reported that the statstrip wireless meter (1.86) s/n: (b)(4) had been sitting in the docking station s/n:(b)(4), while still working, smells like smoke.The customer discontinue use of the meter.There was no patient harm or medical intervention reported.The meter and docking station was returned for evaluation.This is report 2 of 2.The meter and the docking station were returned to nova biomedical for evaluation.Device history record (dhr) reviews for the statstrip 1.86 meter, sn (b)(4), and docking station, sn (b)(4), were performed by a quality engineer.The reviews included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.Upon visual inspection it was observed that the docking station had signs of overheating on the center meter docking contacts and meter docking connector also overheated, damaging the plastic and some contacts.There was a large piece of debris wedged in the docking connector.Upon further inspection, the debris looks to be a piece of metal foil.The metal piece, being highly conductive, shorted several contacts on the dock and meter when the meter was docked.This debris caused several contacts on the dock and meter to short which resulted in overheating and the smell of smoke.It is unknown how this material became wedged in the docking connector, but user error is suspected.Additional materials, which would be more common to become lodged in the devices, were tested and the issue did not recur.Metal materials are not expected to become wedged into these devices and should be avoided as they have low resistance and cause overheating.A corrective and preventive action (capa) is not required as a result of this investigation because the root cause was determined to be metal foil in the docking connector which is most likely related to user error.Trends will be monitored for this or similar complaints.Please see report 1219029-2021-00017.

Event Description

The customer reported that the statstrip wireless meter (1.86) s/n: (b)(4) had been sitting in the docking station s/n:(b)(4), while still working, it smells like smoke.The customer discontinue use of the meter.There was no patient harm or medical intervention reported.The meter and docking station was returned for evaluation.This is report 2 of 2.

• 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: jesus matos ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 11778717
• MDR Text Key: 265023493
• Report Number: 1219029-2021-00018
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1