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

Model Number	54790
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 11778717
• Report Number: 1219029-2021-00018
• Device Sequence Number: 3550720
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1