MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA MAX PLUS BLOOD GLUCOSE MONITOR

Model Number	N/A
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the call to customer support, it was revealed that the complainant did not perform a control solution test for integrity before use their initial test strips as instructed in our directions for use.A control solution test was performed while troubleshooting with customer support showing the test strips to fall in range.The complainant reported he ate a breakfast of pancakes/syrup right after his blood glucose test and then took his 'normal shot of insulin' (20 units novalog) after eating sometime between 10-10:30 am.The complainant also reported, ".He was watching tv around 12:30 pm and he was 'feeling fine'.When he got up to make a sandwich which is the last thing he remembered before 'passing out'.He stated his mother, who lives next door, found him about an hour later and tried to revive him by giving him sugar but she was unsuccessful.She then called the emt's who arrived a few minutes later between 1:30-2 pm.Consumer was unsure of the exact time and order of events as he was unconscious.Complainant stated ".The emt's checked his blood glucose level with their unk meter getting a result of 37mg/dl.He reported that ".One of the emt's then checked his blood glucose level with the nova max plus meter getting a result of 63 mg/dl.During the call to customer support, it was revealed that the consumer did not perform a control solution test for integrity before use their initial test strips as instructed in our directions for use.Per label copy/ package insert: high or low blood glucose results can indicate potentially serious medical conditions.In case of an unexpected result, you should repeat the test using a new test strip.If the result is still unexpected, or the reading is not consistent with how you feel, contact your hcp and treat as prescribed.Any change in the treatment of your diabetes should be discussed with your hcp.Nova max test strip insert- quality control: checking the system control solution test: the nova max control solution is used as a quality control check to make sure that your blood glucose monitor and the nova max glucose test strips are working correctly.Do a control solution test: each time you open a new vial of test strips.Storage and handling keep the nova max glucose test strips vial tightly closed when not in use.Test strips should be stored only in the original vial.Meter and test strips are expected to be returned for evaluation.
Event or Problem Description
Complainant called into customer care reported he experienced an hypoglycemic event that required medical intervention.According to the complainant, sometime between 10:00am and 10:30am, he ate breakfast of pancakes and syrup and took his 'normal' shot of 20 units of insulin.Complainted reported 'around' 12:30pm he was 'feeling fine' got up to make a sandwich and the last thing he remembers is ".Passing out.".
Additional Manufacturer Narrative
Complaint is confirmed.Failure analysis of the returned device revealed that the nova max plus glucose monitoring device performed within specification.Visual as well as chemical evaluation (by testing with control solution) of the returned glucose test strips revealed the strips to be compromised.The root cause could not be conclusively identified.A potential contributory root cause may be related to exposure of the test strips to extremes in temperature contrary to the storage and handling as indicated in label copy (ifu/package insert) this is further supported by the results of the retain strip testing which indicates the performance of the retain strips are within product specification.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.

• Brand Name: NOVA MAX PLUS BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prosopect street; waltham MA 02454
• MDR Report Key: 6586963
• Report Number: 3004193489-2017-00019
• Device Sequence Number: 10947443
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020316111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1