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

Model Number	1.75
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The facility did indicate "the baby's results have since been in the 70s and 80s".The customer "thinks the result of 13 mg/dl is an outlier" and that the" baby may not need to be in the nicu".Product identification (meter serial number and glucose test strip lot number) have not been provided by the facility.The facility contact did confirm that qc was run on the meter and passed.
Event or Problem Description
Facility called to report concern regarding a patient (baby) glucose result.Due to the result the baby was moved to the nicu.
Additional Manufacturer Narrative
Customer complaint was not confirmed.No product was returned for evaluation.A review was conducted for the lot available for use on or around the time of the event and lot# 0316201249 was identified.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 alleged deficiency could not be replicated.

• Brand Name: STATSTRIP
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 6513482
• Report Number: 1219029-2017-00005
• Device Sequence Number: 385842
• Product Code: CGA
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1.75
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other