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	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	08/03/2019
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 1.3¿a.The criteria is <55¿a.Pass.Meter setting, audio and all buttons function are ok.Because patient did not return her strips, only returned meter, so we tested the suspected meter with in house control solution and our retain strips (same as patient's strip, lot number: d181114-2 ).The control solution tests for level low were 63/61 mg/dl; for level high were 247/247 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
End user stated that medical attention was sought on (b)(6) 2019 around 8pm at the end user's home.End user stated she fell asleep on a chair and her daughter attempted to wake her around 8:00pm.The end user was feeling confused and was not verbally responding to her daughter.End-user stated that her daughter gave her 2 glucose tablets via mouth and tested her blood glucose on her prodigy meter and received a result of 95 mg/dl.Her daughter called paramedics about 10 minutes after testing with her prodigy meter.Paramedics arrived.Approximately 15 minutes later and tested the end user's blood glucose and received a result of 52 mg/dl.The paramedics administered glucose though an iv and transported her to (b)(6) hospital.Upon arriving at the hospital, the end user had a blood glucose of 138 mg/dl.The doctors gave the caller some apple juice and chicken on a roll.The end user was not admitted to the hospital and was discharged after 4 hours with a blood glucose of 140 mg/dl.

• 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: 8987598
• Report Number: 3005862821-2019-00042
• Device Sequence Number: 16989353
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/12/2019

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 Expiration Date: 11/14/2020
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D181114-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/11/2019
• 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: 78 YR
• Patient Weight: 86