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

Catalog Number 53398

Device Problems Changes In Ambient Temperature In Device Environment (1027); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Meter docking station overeating occurred during cleaning and storage of meter into docking station.Customer cleaned meter and returned while still saturated with fluid to the quad docking station which resulted in overheating.

Manufacturer Narrative

Corrected data: serial number of meter added.The meter and docking station were returned for evaluation.The complaint is confirmed.Visual examination of the returned products are consistent with the event description where the devices present with damage by heat subsequent to cleaning the meter and returning the device to the docking station while saturated with fluid.Ingress of fluid into the j6 connector in the meter caused a resistive bridge in the connector.Power supplied to the meter by the docking station caused the bridge to generate heat.Confined to the docking station, the heat caused damage to the meter and docking station.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer Contact: paul macdonald ; 200 prospect st; waltham, MA 02454-9141 ; 7818940800
• MDR Report Key: 6041891
• MDR Text Key: 57929139
• Report Number: 1219029-2016-00002
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2013
• 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