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

Model Number	51850
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Sweating (2444)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that the meter was broken by connector deformation.When we inserted strips into meter, meter was able to turn on, but meter was not working when we tried to apply control solution or blood to test strip.We tested the returned strips with our in house meter and control solution (strip lot number: d181119-1).The control solution tests for level low were 67/72 mg/dl, for level high were 240/243 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.So we concluded the meter was out of work because of connector deformation.The pin deformation of the connector is caused by the reverse insertion of the test strip.User operation issue.
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 at her home.End-user stated that she received a result of lo when testing her blood sugar.End-user then stated that she tried testing with her prodigy meter 10 times and continued to get a reading of lo.She then tried to raise her blood sugar by eating cake cookie and juice.She then said she started sweating and had feelings of nervousness.End-user stated she took metformin 1000mg/dl.She proceeded to drive herself to the emergency department where upon arrival her blood glucose was 188mg/dl.She was not treated for her blood glucose due to her level being ok when she arrived at the hospital.She stated that she was prescribed amoxicillin 500mg/dl but did not disclose why she was given the antibiotic.End-user was told to follow up with her primary care dr.She was treated at (b)(6) hospital located at (b)(6) for 5 hours and was not admitted.

• 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: 8963883
• Report Number: 3005862821-2019-00038
• Device Sequence Number: 2521233
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/07/2019

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: 11/19/2020
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D181119-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/05/2019
• 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: 61 YR
• Patient Weight: 88