MAUDE Adverse Event Report: OSANG HEALTHCARE BLE SMART BLOOD GLUCOSE MONITORING SYSTEM; GLUCOSE DEHYDROGENASE, GLUCOSE

Model Number	BLE-SMART-TS50-FDA
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customers that received lot b18j19-5b1 were identified and will be instructed with a notice via email to discontinue use of the test strips immediately.
Event or Problem Description
Medwatch report number mw5090833 was reported to entra health on november 14 2019.Complainant informed entra health systems on november 4 2019 of an issue stating that the ble smart from lot b18j19-5b1 was giving higher than normal readings when comparing meter readings against the freestyle lite meter.In addition, the complainant stated the meter was giving readings out of the acceptable range of 0-20% error.

• Brand Name: BLE SMART BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): OSANG HEALTHCARE; 132, anyangcheondong-ro; dongan-gu; anyang, republic of korea 14040 ; KS 14040
• MDR Report Key: 9406931
• Report Number: 3004146366-2019-00001
• Device Sequence Number: 16829131
• Product Code: LFR
• UDI-Device Identifier: 00850081003960
• UDI-Public: 850081003960
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/03/2019
• Report Date (Section F): 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: BLE-SMART-TS50-FDA
• Device Lot Number: B18J19-5B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1