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

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 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Patient was treated with glucose tablets/glucose gel.No adverse event was reported.No additional event or patient information is available, thus it is unknown if patient was a good candidate for a finger stick glucose test.Healthcare providers should be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result.Evaluation of retain strips and dhr review was completed.The customer complaint cannot be replicated with retained strips.Evaluation of returned meter and strips is to be performed upon device return, expected 08/02/2019.

Event Description

Discrepant glucose patient results using nova statstrip xpress 2 glu/ket meter when compared to lab reference analyzer.

• 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 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02454-3465 ; 7816473700
• MDR Report Key: 8852439
• MDR Text Key: 168215788
• Report Number: 1219029-2019-00035
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/29/2020
• Device Model Number: 42214
• Device Lot Number: 0317233309
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 08/01/2019
• Date Device Manufactured: 08/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1