MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY AUTO CODE; BLOOD GLUCOSE MONITORING DEVICE

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Confusion/ Disorientation (2553)

Event Date 11/26/2022

Event Type  Injury  

Event Description

Caller stated that medical attention was sought on (b)(6) 2022 around 8:30pm at home.Caller stated that she performed a blood glucose test with her prodigy meter and received a result of 150mg/dl.A normal result for that time of day is usually around 113mg/dl.Caller stated that she tests her blood glucose 4 times a day.Caller stated that she took her medication as prescribed see all that are listed.Caller stated that she started to feel confused and daze and had someone take her to (b)(6).Caller stated that when she arrived at the hospital her blood glucose was 43mg/dl.She does not recall how much time passed between testing with the prodigy meter and her going to the hospital.Caller stated that she was at the hospital for 5-6 hours.Caller stated that her vitals were checked along with testing for a uti.Caller stated that no changes were made to her diabetic medication before or after seeking medical attention.Caller stated that she does not recall what her blood glucose was prior to being discharged.No additional information was provided.

• Brand Name: PRODIGY AUTO CODE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 15999946
• MDR Text Key: 305679784
• Report Number: 3008789114-2022-00014
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00384841518505
• UDI-Public: (01)00384841518505
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2022
• Distributor Facility Aware Date: 11/29/2022
• Event Location: Home
• Date Report to Manufacturer: 12/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ATORVASTATIN; FENOFIBRATE; HUMALOG; JARDIANCE; LANTUS; LASIX; LOPRESSOR; MAGNESIUM; METAMUCIL; METFORMIN; METOLAZONE; PREVAGEN; PROTOCHLORIDE; SENOKOT; VITAMIN B; VITAMIN C; VITAMIN D13,; WARFARIN; ZINC
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 101 KG