MAUDE Adverse Event Report: OK BIOTECH C., LTD. PRODIGY VOICE; BLOOD GLUCOSE MONITORING DEVICE

Model Number	51900
Medical Device Problem Codes	Corroded (1131); Battery Problem (2885)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspected meter was evaluated by ok biotech.Error message "e-b" means battery cannot provide enough power for a test.After we placed new batteries into meter, the meter still showed e-b.We check battery compartment and found the corrosion because of battery leakage.User might exposed meter to water or high temperatures or did not use the meter for more than 3 months but keeping batteries into meter.
Event or Problem Description
End-user alleged that on (b)(6) 2018 around 0730 the paramedics were called due to symptoms of hypoglycemia.End-user alleged the meter would not provide a result and would display the low battery error code, e-b.It is unknown when the end-user last received a numerical result on the prodigy meter.Paramedics arrived and performed a blood glucose test on the end-user and received a 20 mg/dl with their meter.End-user was treated with iv fluids (unknown concentration of fluids) to raise his blood glucose.End-user was transported to the hospital, upon arrival end-user alleged his blood glucose was 20 mg/dl and he received more iv fluids to raise his blood glucose level.End-user remained in the hospital for 5 days and no other treatment was provided.Upon discharge the end-user's blood glucose was reported to be 180 mg/dl.End-user was advised to follow up with pcp and to start a sliding scale with basaglar.End-user stated he did not know the prescribed sliding scale.No additional details were provided in regards to this medical event.

• Brand Name: PRODIGY VOICE
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH C., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu, 30070 ; TW 30070
• MDR Report Key: 7548144
• Report Number: 3005862821-2018-00029
• Device Sequence Number: 13906745
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K073118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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 Model Number: 51900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 84