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

Model Number 42214

Device Problem Low Readings (2460)

Patient Problems Hypoglycemia (1912); No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the device is 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 the patient in the nicu had a low glucose reading and was exposed to animal milk proteins and or iv for treatment.It was also stated that there were other incidents of low glucose readings.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 protein or iv provided to this patient or any of the other incidents mentioned.

Manufacturer Narrative

Corrected information: b4, g4, g7 additional information: h2, h6, h10 udi: (b)(4).As reported by the customer, the patient had discrepant glucose reading results.The complaint sample was not returned to nova; therefore, an evaluation of the sample could not be performed.However, nova was able to perform an evaluation on retain strips from the same lot.The device history record (dhr) reviews for the statstrip glucose test strip lot number 0319114309 and all meters provided by the customer, were performed by the quality control engineer.The review included an assessment of the production, testing, and release of the meters and test strip batch.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.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.The data meets the fda's acceptance criteria with much of the comparative data within+/- 5 mg/dl of the reference method and most within +/-10 mg/dl.This type of variability is expected against central laboratory systems.This shows that with proper sample collection and handling the system reports accurate results.Based upon this investigation, it was determined that the incident occurred probably due to user error, not following the proper specimen handling technique for neonatal capillary heelstick sampling (use of heel warmer and site preparation).Nova biomedical has previously acknowledged the deficiencies in customer awareness of proper heelstick sampling technique for neonates by revising ifus to provide additional guidance for site preparation when testing neonates.Customer training was also conducted by field support and no other actions are warranted at this time.Trends will be monitored for this 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: 10083096
• MDR Text Key: 198749548
• Report Number: 1219029-2020-00038
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: 42214
• Device Catalogue Number: 42214
• Device Lot Number: 0319114309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1