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

Model Number	N/A
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant reported he is utilizing four different vials of ts that he believed are giving him false readings.During the call into customer care, the complainant reported an 'incident' that happened on "10/04".He reported, ".When he was talking on the phone with his sister later at night when she expressed her concern when he started to sound incoherent." he stated, ".His sister called the neighbor who assisted him with having "some oj and peanut butter." the complainant decline to provide further details about the incident or provide any details about what happened earlier in the day (treatment, readings, food.) he also refused to continue with providing readings from the meter memory.He stated, ".I've been a diabetic for a "a very long time and i know what i am doing." when he was asked if at any point during the day he treated himself bases on results obtained from meter; he responded ".That i don't have my doctor with me 24h a day to tell me what to do." he stated, ".I didn't go the hospital." the complainant could not confirm which vial he was using at the time of the incident.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 reported an incident that happened on (b)(6) 2017 when he was talking on the phone with his sister later at night when she expressed her concerns when he started to sound incoherent.
Additional Manufacturer Narrative
Complaint is confirmed.Failure analysis of the returned device revealed that the nova max link 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 LINK BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prosopect street; waltham MA 02454
• MDR Report Key: 6957696
• Report Number: 3004193489-2017-00029
• Device Sequence Number: 903105
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040603
• 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): 10/09/2017

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: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: 1020215306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1