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

Model Number	53401
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nova biomedical opened an internal investigation to evaluate the returned docking station, sn (b)(4), and meters, sn (b)(4).
Event or Problem Description
On (b)(6) 2019 nova was made aware of an issue regarding nova stat strip docking station, sn (b)(4), sparking and smoking.
Additional Manufacturer Narrative
Device investigation: the device history records (dhrs) were reviewed by the senior quality control manager, and indicated that the released product met all specifications.The two meters were inspected and performed as inspected, with no failures found.Disassembly of the docking station showed evidence of overheating.There was also evidence of debris and fluid ingress inside the docking station, which was likely caused by fluid spillage.The safety measures built into the docking station design caused the adaptor board connector to melt instead of catching fire.Since this docking station was manufactured, the adaptor board fuse has been moved to the underside of the docking station board to protect it from fluid ingress, moving the point of power interruption upstream.This will prevent the issue from re-occurring under similar circumstances.As a result of the investigation, the complaint has been confirmed.Based on the evidence of the damage, the root cause has been determined to be improper user handling.

• 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 3465
• MDR Report Key: 9117805
• Report Number: 1219029-2019-00050
• Device Sequence Number: 390589
• Product Code: PZI
• UDI-Device Identifier: 00385480534017
• UDI-Public: 00385480534017
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1