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

Model Number	51850
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Fainting (1847); Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.We tested the standby current of returned meter, the result was 1.7ua.The criteria is <55ua.Pass.Meter setting, audio and all buttons function are ok.Because patient did not send back her strips, so we tested the suspected meter with in house control solution and in house strips (strip lot number: d180315-1).The control solution tests for level low were 64/67 mg/dl, for level high were 255/263 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 210~320 mg/dl.All results were within the acceptance range.Pass.
Event or Problem Description
Reporter stated that medical attention was sought on 7-20-2019 around 12pm.End-user was eating and stated they needed to go to the bathroom.End-user took glipizide prior to dinner, they fell over in their chair and was too weak to move.Reporter helped end-user to the bathroom and performed a bgt, meter read 379mg/dl.Caller picked up the end-user and brought them to their bed and called the paramedics.Paramedics arrived about 25 minutes later, enduser was responsive but was confused.Paramedics performed a bgt on their meter and it read 25mg/dl and then performed a bgt on the prodigy and received a result of 178mg/dl.Paramedics gave the end-user glucose through an iv.The paramedics transported the end-user to the er where upon arrival her blood glucose was 32mg/dl when tested with the hospitals meter.She was then admitted for 2 days.Caller does not remember what other bgt were performed or the discharge result.The doctor took the end-user off the glipizide after medical attention was sought.A cat scan was performed, and the results were normal.She was treated at (b)(6) medical center emergency room located at (b)(6).

• Brand Name: PRODIGY AUTOCODE
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 8886285
• Report Number: 3005862821-2019-00037
• Device Sequence Number: 14276437
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/12/2019
• 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
• Patient Age: 80 YR
• Patient Weight: 48