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

Model Number	N/A
Health Effect - Clinical Code	Sweating (2444)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the distributor, (b)(4) at (b)(4), the complainant reported, ".Insulin injected before dinner.The test was done and the gluc-o-meter throw a value of 170 mg/dl (she injects insulin again) and then experiences 'night sweats' therefore she makes the test again and the value is 70 mg/dl.She says, ".The gluc-o-meter never throws estables values." she says, ".She is on diet because of high cholesterol and a cancer patient." the reporter was not able to provide any further information regarding the reported event.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.
Event or Problem Description
The complianant experienced 'night sweats' after administering addtional insulin.

• 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: 6770615
• Report Number: 3004193489-2017-00024
• Device Sequence Number: 1615339
• Product Code: NBW
• UDI-Device Identifier: 00385480434355
• UDI-Public: 00385480434355
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K091547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 43435
• Device Lot Number: 1020215341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1