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

Model Number 1.86

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2021

Event Type  malfunction  

Event Description

Nova biomedical (nova) was made aware of a situation where an inaccurate result for glucose was received while using a statstrip glucose meter, serial number (b)(4) with test strip lot 0320113309.It was observed the glucose discrepancy for the heelstick test was observed for a neonate patient.The nurse questioned the results before any treatment was given.An additional sample was run across the meter and confirmed the initial results were incorrect.No patient harm or adverse treatment due to the inaccurate results was reported.

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Manufacturer Narrative

There is currently a pending investigation.The device was received by the nova subsidiary on 11/25/2021.Nova corp is requesting additional information, and further details will be provided in a supplemental report.

Manufacturer Narrative

The customer reported an incorrect patient result for glucose was received when running a neonatal patient sample on a statstrip glucose meter with sn (b)(6) using the test strips of lot 0320113309.This occurred on (b)(6)2021.The meter did not indicate there was a problem with the sample in anyway before producing the result but the nurse questioned the results before any treatment was given.There was no harm or adverse treatment due to the inaccurate results.The meter and test strips were not returned to nova biomedical for investigation.The manufacturer retains of strip lot 0320113309 were tested on five statstrip glucose meters.All tests passed the acceptance criteria for linearity solutions and blood samples when ran for 10 sets, analyzing four replicates with each set.No discrepancies were observed between blood results obtained by the retained test strips when compared to a reference analyzer.Device history record (dhr) reviews were performed for the meter and test strips being used at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter and test strips.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be confirmed after testing the manufacturer retains of the test strips.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 12797732
• MDR Text Key: 283428437
• Report Number: 1219029-2021-00048
• Device Sequence Number: 1
• Product Code: PZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.86
• Device Catalogue Number: 54794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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
• Patient Age: 1 DA
• Patient Sex: Female