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

Model Number	54790
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is investigating the returned meter and further details will be provided in a supplemental report.
Event or Problem Description
The customer reported seeing sparks come from a statstrip 1.86 meter with serial number (b)(4) on july 23rd.The battery compartment had the battery cover in place and the sparks were still visible.The screen was flashing on the meter, something it is not intended to do.The meter was taken out of service and no patient harm occurred.
Additional Manufacturer Narrative
Udi: (b)(4).The customer reported a statstrip glucose meter with serial number (b)(6) was being used when the screen started flashing and sparks were seen from the enclosed battery compartment.This occurred on july 23, 2021.The meter was taken out of service, and therefore, did not result in patient or user harm.The meter was returned to nova biomedical corp.For investigation.The investigation resulted in the determination the back-up, button-cell battery had become dislodged after the supplier adhesive seal failed.The battery then shifted within the device to a position where it was in contact with other powered electrical components, allowing the battery to overheat.Device history record (dhr) reviews were performed for the meter by a quality control engineer.The review included an assessment of the production, testing, and release of the meter.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.A review of manufacturing variance documents showed this problem was previously documented and a corrective action had been implemented after the manufacture of the meter under investigation.The corrective action includes a uv-cured adhesive to secure the button-cell battery in the proper position.The conclusion of the investigation is the reported customer complaint was due to the dislodgment of the internal button-cell battery from the proper positioning.The root cause was identified as a failure in the supplier adhesive seal designed to keep the internal battery in the proper position.Nova biomedical will continue to monitor for recurrence of similar events.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 12349570
• Report Number: 1219029-2021-00028
• Device Sequence Number: 14456698
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: No Information
• Device Model Number: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1