MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP STATSTRIP XPRESS GLU - TEST STRIPS

Model Number 42214

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the devices are still in use and are not available for return.An investigation is currently underway based on the information provided and a device history record (dhr) review has been requested as well as testing of the statstrip retains.A supplemental report will be submitted upon completion.

Event Description

The customer stated that multiple patients in the nicu had fluctuations of low glucose readings while using statstrip glucose meter v1.86 serial numbers (b)(4) and (b)(4) utilizing stat strip test strips lot# 0319081249.Multiple attempts were made to receive specific results and or patient specific information, however; no further information has been provided by the facility.There is no further indication of additional treatment and or patient harm resulting from the reported low glucose readings.

Manufacturer Narrative

Udi: (b)(4).Initial testing of retained sample of statstrip glucose test strip, lot# 0319081249 was performed on 24aug20.A device history record (dhr) review included an assessment of the production, testing, and release of the test strip batch.No abnormalities or concerns were observed and the product lot met specifications upon release.Testing was performed on retained strips, lot# 0319081249, which met the performance acceptance criteria for linearity solutions and whole blood samples with no discrepant values obtained.Based upon this investigation, it was determined that the incident occurred probably due to use error, not following the proper specimen handling technique for neonatal capillary heel stick sampling (use of heel warmer and proper site preparation).Nova previously performed a comprehensive study on four (4) different lots of statstrip glucose test strips, ages 3, 6, 12, and 18 months.The study evaluated samples with low glucose concentrations and high hematocrit concentrations to simulate venous whole blood neonatal blood specimens.All data met the fda's acceptance criteria.This shows that with proper sample collection and handling the system reports accurate results.Nova is also in the process of revising ifus for the appropriate products to include additional guidance for site preparation and heel stick sample collection for neonates.This effort is being completed via preventive action.The conclusion of the investigation, is that the reported issue, discrepant neonatal glucose results could not be reproduced.No root cause was able to be identified, but based on the information described in the investigation, use error is suspected.Trending will be monitored for this and or similar complaints.

• Brand Name: STATSTRIP STATSTRIP XPRESS GLU - TEST STRIPS
• Type of Device: STATSTRIP
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham, ma
• MDR Report Key: 10410194
• MDR Text Key: 205500557
• Report Number: 1219029-2020-00042
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42214
• Device Catalogue Number: 42214
• Device Lot Number: 0319081249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1