MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP., NOVA MAX LING BLOOD GLUCOSE MONITOR

Model Number	N/A
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant reported, ".She ate fruit and oatmeal around 12:00 pm." the complainant's pump dispersed an unknown amount of insulin based on her blood glucose results.Subsequently, the complainant experienced an event where her she was found unresponsive approximately at 4:50 pm by her brother in law.He contacted the emt's right away.According to the complainant's brother in law the emt's arrived at 5:05 p and found they were unable to put an iv in and transported her to: (b)(6).It was reported that when she arrived at the emergency room, approximately at 5:15 pm the complainant stated the doctor started her on an 'iv'.The complainant was unable to provide any further information regarding results and other treatment that took place in the emergency room; other than she was there for 3-4 hours and discharged at 9:00 pm.When she arrived home she ate toast with juice and went to sleep.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 is expected to be returned for evaluation.Reference: 3004193489 2017-00009.
Event or Problem Description
Complainant called in reporting high blood glucose readings.
Additional Manufacturer Narrative
The alleged deficiency could not be confirmed.Although the reported results were found in the memory of the returned device, failure analysis of the returned product revealed that the novamax link meter glucose monitoring device performed within specification.The dhr for the meter complete and contained all relevant data indicating the product put into finished goods met all specifications.Retain test strip testing could not be performed nor could a dhr be provided as the complainant was unable to provide test strip information.

• Brand Name: NOVA MAX LING BLOOD GLUCOSE MONITOR
• Common Device Name: BLOOD GLUCOSE MONITOR
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.,; 200 prospect street; waltham MA 02454
• MDR Report Key: 6376126
• Report Number: 3004193489-2017-00008
• Device Sequence Number: 797813
• Product Code: NBW
• UDI-Device Identifier: 00385480445856
• UDI-Public: 00385480445856
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/21/2017

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 Model Number: N/A
• Device Catalogue Number: 44585
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1