MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STATSTRIP GLUCOSE METER; UNKNOWN

Model Number UNKNOWN

Device Problem Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

Nova biomedical was made aware of a customer event that took place utilizing a statstrip glucose meter on a neonate on december 12, 2020 by the fda via postal mail.There has been no communication directly from the customer regarding this event.Nova inquired to the fda if additional information could be provided and was informed that the reporter identity is confidential.A complaint sample was not returned to nova and no serial or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.There is also no information pertaining to any alleged patient harm or intervention.The cause(s) of the difficulty reported by the fda could not be determined or if there were several events.This complaint will be closed as 'no complaint sample returned to nova for evaluation'.If the complaint sample and or additional information regarding this event becomes available, this complaint will be reopened, and the respective evaluation performed.No corrective action is required based on the above information.

Event Description

An unknown customer reported to the fda that statstrip glucose meter alleging that the device returned incorrect glucose values for premature infants.The customer performed a test on (b)(6) 2020.The following glucose results on the test were returned: "test results: poc at 12:02 = 22 so a correlation lab value ordered at 12:20 the poc for 2 different machines #1 = 35, #2 = 37.The lab values at 12:24 = 52.Glucose results are all very different from the poc glucose machines.

• Brand Name: STATSTRIP GLUCOSE METER
• Type of Device: UNKNOWN
• 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: 11565031
• MDR Text Key: 243534268
• Report Number: 1219029-2021-00015
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

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
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1