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

Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because device was not return to ok biotech, therefore, we were unable to perform further testing on the suspected device.We are unable to confirm the complaint because device was not returned and no further information from customer has been received, this matter has to be closed out with undetermined root cause.
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019.Reporter stated that her father has been to the emergency room due the false high results.Caller stated she called ems due to her father having low blood glucose, but his meter did not give him a low result.She stated that she called ems and they tested with their meter and received a result lower than 20 and when they tested him on his prodigy meter they got a result of 111 mg/dl.Caller stated that he was transported to the hospital.The caller did not give any information on the emergency room visit she stated she threw away all his prodigy products.The caller also stated that she was comparing her fathers prodigy meter to a contour and the prodigy gave higher results.Caller did not provide any medications preexisting conditions or any other information.

• Brand Name: PRODIGY VOICE
• 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: 8928983
• Report Number: 3005862821-2019-00035
• Device Sequence Number: 19384618
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 073118
• 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): 07/22/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/25/2019
• 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: 83 YR