MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP; GLUCOSE TEST SYSTEM

Model Number 1.86

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Renal Failure (2041)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient had just returned from dialysis when the initial glucose tests (finger sticks) were done.According to the nurse, the patient was not "deemed critically ill and seemed to be a good candidate for the fingerstick (i.E.No edema, no peripheral blood flow issues, etc.).The meter did not generate any 'bad sample" errors.The difference between the results obtained on the statstrip system and the lab value was found to be clinically significant.

Event Description

Facility reported discrepancy between statstrip capillary blood glucose vs.Lab (sample unknown) blood glucose value on patient who returned from dialysis.Patient was given "oj & crackers".The patient was due for discharge, however the facility reported, the patient was kept an extra day to monitor".

Manufacturer Narrative

Customer complaint was not confirmed.No product was returned for evaluation.A dhr review of the test strip lot was performed.The dhr was complete and contained all relevant data indicating that the released product met all specifications.Retained test strips for this lot were tested as part of the complaint investigation.The test strips met all performance test specification and no discrepant values were obtained.The customers alledged defiecency could not be replicated.

• Brand Name: STATSTRIP
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02451
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning road; billerica MA 01821
• Manufacturer Contact: rachel kula ; 200 prospect street; waltham, MA 02451 ; 9784393638
• MDR Report Key: 6509100
• MDR Text Key: 73517525
• Report Number: 1219029-2017-00004
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 1.86
• Device Catalogue Number: 54790, 42214
• Device Lot Number: 0316184249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Hospitalization