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

Model Number	N/A
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the daughter, the complainant ate later than usual on (b)(6) 2018 around 8:00 pm and her 'normal' dinner time is usually between 5:00 - 6:00 pm.The caller also reported that the user performed a blood glucose test at 8:26 pm getting a result of 72 mg/dl according to the caller, her mom then ".Ate some cookies to raise her blood glucose level, because a result of 72 mg/dl is a little bit 'too low' for this time of night for her." caller confirmed no insulin was administered at this time.The caller reported, ".Her mom woke up at 5:24 a on (b)(6) 2018 performed a glucose test getting a result of 82 mg/dl.Approximately 9:00 am the daughter reported that her mother administered her daily standard 65 units of insulin which is her daily routine and as instructed by her doctor.After the insulin intake, the mother ate breakfast consisting of a sandwich.According to the caller, she noticed her mother 'acting strangely' and became 'combative' when asked to perform a blood glucose test.The daughter notice her mother became 'non-responsive' so she called 911." emts arrived around 10:00 am and in a few minutes later they performed a blood glucose test using their unknown brand meter getting a result of 'lo' indicating a result lower than 15 mg/dl.Complainant was treated with iv glucose and a 'glucose drink'.According to the caller, she was not able to provide the exact time when the emts performed a 2nd test getting a result of 72 mg/dl on their meter and one on the nova max plus getting a result of 82 mg/dl.The caller began to feel better and declined to be transported to the hospital.The reported time does not reflect the time stored in the meter.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's daughter called in reporting an incident on (b)(6) 2018 where her mother ".Experienced a 'hypoglycemic event' and the emt's were called to the house.".
Additional Manufacturer Narrative
Complaint is not confirmed.The reported results were found in the memory of the returned device.The meter history does reveal that the time is incorrect and does not align with the reported details.According to the meter history, the complainant performed additional tests after administering her 65 units of insulin which as instructed by her hcp to take every morning, she then ate a sandwich for breakfast.According to the meter history, it shows that the complainant performed two more glucose tests over the next two hours getting results of 83 mg/dl at 05:42 and a 95 mg/dl at 06:07.The meter history shows the next blood glucose test was performed was performed approximately 18:39 getting a result of 344 mg/dl.Failure analysis of the returned product revealed that the nova max plus glucose monitoring device performed within specification.The complainant did not return the test strips in question; qa retain test strips from the same lot were utilized to complete the investigation.Results obtained were within specification.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.Complaint is not confirmed.Although the reported results were found in the memory of the returned device.The meter history does reveal that the complainant's blood glucos results are much lower in the evening than the early morning.Failure analysis of the returned product revealed that the nova max plus glucose monitoring device performed within specification.The complainant did not return the test strips in question; qa retain test strips from the same lot were utilized to complete the investigation.Results obtained were within specification.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.
Additional Manufacturer Narrative
Complaint is not confirmed.The complainant did not return the glucose meter or the test strips in question.Although the complainant did not return the blood glucose test strips in question, qa retain test strips from the same lot were utilized to complete the investigation.Results obtained were within 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 MONTITOR
• Common Device Name: BLOOD GLUCOSE MONTITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02451
• MDR Report Key: 7428260
• Report Number: 3004193489-2018-00002
• Device Sequence Number: 13943966
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K09147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2018

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: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020917321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 04/09/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/14/2018; 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1