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	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant reported that he tests 8 times/day and administers insulin after each result if the sliding scale calls for it; if his blood glucose level is "good" he does not take insulin.According to the complainant, he performed a blood glucose test getting a results 214 mg/dl at 5:20 am.Based on that result and according to his sliding scale he administered 30 units of 'short term humalog'.The complainant reported he ate breakfast and at 6:13 am he performed another blood glucose testing getting a result of 232 mg/dl.Based on that result and his sliding scale, he administered an additional 20 units of humalog insulin based on his sliding scale because his blood glucose level had not gone down.Shortly thereafter, the complainant was unclear on exact times due to the nature of the incident but he 'believes' it was around 8 am, he walked downstairs to meet a friend and he passed out at the foot of the stairs; he stated there was no "warning" or symptoms prior to collapsing.According to the complainant, ".Somebody must have called the emt's." and when they arrived they checked his blood glucose with their unk meter and the result was 60.They gave him some glucose gel and he' came to.' he was given a sandwich.The emts checked his blood glucose levels again and it went up to 80 mg/dl.Complainant declined a trip to the hospital as he was 'feeling much better.' he reported that he went out with a friend to the store for a couple of hours and upon returning home checked his bg again.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 reporting ".A hypoglycemic incident." where he passed out and required medical intervention.
Additional Manufacturer Narrative
Complaint is confirmed.The complainant did not return the nova max plus meter in question.Evaluation of the returned test strips read high out of control range.The root cause is attributed to the consumer's storage and handling of the test strips as evidence by the weight of the returned vial failing the weight test.A failure of this nature is consistent with a compromised vial by exposure to humidity and/or fluid.This finding is further supported by the results of the retain strip lot testing which confirms the retain strips to perform 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 MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect street; waltham MA 02451
• MDR Report Key: 6670780
• Report Number: 3004193489-2017-00023
• Device Sequence Number: 1971247
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020216321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1