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

Model Number 51850

Device Problem High Readings (2459)

Patient Problems Fever (1858); Pallor (2468)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

1.No nonconformance was found in the document (qa-w-21-03) after okb reviewed device history record (dhf) of the suspected meter (serial#: (b).(4) 2.The meter was shipped to pdc on 2019-12-17.Because the suspected meter was not returned to okb, the retained one (serial#: ok-a-qc-01) was used to re-examine its setting and all functions, and no malfunction occurred.Also, it was re-tested by any retained strips (lot#: d210611b-1) from okb's warehouse and any valid control solutions (batch# of gcs level low: 0ah1a03 and exp.By 2022-12-31; batch # of gcs level high: 0ah3a17 and exp.By 2022-12-31).Gcs test results (level low: 49/48; level high: 286/288) met the acceptance criteria (level low: 30~75; level high: 230~340).3.The root cause of the complaint was unable to be verified without the suspected meter and more critical information.Therefore, the complaint has to be closed out if no further action or information from the user.

Event Description

Caller stated that she sought medical attention on (b)(6) 2022 around 12:00pm at home.Caller stated that she tested the end-users blood glucose with his prodigy meter and received a result of 258mg/dl.A normal result for him is usually around 130mg/dl.Caller stated that the end-user was pale and had a fever 4-5 minutes after testing.Caller stated that he did not have any medication prior to testing.Caller stated that there was no food drink or medication consumed while waiting for the paramedics to arrive.Caller stated that the paramedics arrived within 5 minutes.Caller stated that the paramedics did not test the end-users blood glucose at all.End-user was transported to (b)(6) hospital located at (b)(6).Caller stated that she does not recall what the end-users blood glucose was upon arriving to the hospital.Caller stated that the end-user was admitted to the hospital.Caller stated that the end-user was given an antibiotic and insulin.Caller stated that the end-user was discharged after 5 days with a blood glucose of 147mg/dl and was told to continue the antibiotics and insulin and follow up with his primary doctor.There were no changes to the end-users medication prior or after seeking medical attention.No additional information was provided.

• Brand Name: PRODIGY AUTOCODE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 16057858
• MDR Text Key: 306241076
• Report Number: 3005862821-2022-00016
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

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
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GLYXAMBI; METFORMIN; SIMVASTATIN
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 111 KG