MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP; GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE

Model Number 42214

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

No patient impact, investigation pending.Site preparation and heelstick technique may have caused result discrepancy between the statstrip meter and lab reference analyzer.Returned and retained test strips, from the same batch, will be evaluated once the returned product received by the manufacturer.The statstrip glucose hospital meter (p/n 54794 s/n (b)(4)) will not be returned for investigation as it has passed additional quality control testing at the facility, the investigation will instead be focused on the statstrip glucose test strips (p/n 42214 lot 0317191309).

Event Description

Discrepant patient results on a nova statstrip glucose hospital meter for heelstick samples from a healthy newborn in the nursery.

• Brand Name: STATSTRIP
• Type of Device: GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02454 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02454-3465 ; 7816473700
• MDR Report Key: 8073616
• MDR Text Key: 128404534
• Report Number: 1219029-2018-00006
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2018

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: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: 42214
• Device Lot Number: 0317191309
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/15/2018
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1