MAUDE Adverse Event Report: APEX BIOTECHNOLOGY CORP. GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM

Model Number	571100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter was returned to arkray (importer) and investigated.Corrosion was found inside the battery compartment.Corrosion was cleaned and new batteries were inserted into the meter.Meter would then work for testing and performed to specification.Apex (manufacturer) received the return of subject meter and evaluated.Fluid leakage found on pcba.Performed control solution test to returned meter and retain meter, all values were within the control solution range.The returned meter gave results in mg/dl format.Evidence of evaluation is attached.Corrective actions are initiated to improve the potential problem.
Event or Problem Description
No physical damage to the meter.No debris around the test strip port.Customer stated that her meter started to read her results as mmol.Walked customer through a proper blood test and she received a reading of 8.9 mmol.The meter read the results out loud as mmol.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no.7 li-hsin road v; hsinchu science park; hsinchu, taiwan 30078 ; TW 30078
• MDR Report Key: 9789789
• Report Number: 9616936-2018-00001
• Device Sequence Number: 2185254
• Product Code: NBW
• UDI-Device Identifier: 00015482570101
• UDI-Public: (01)00015482570101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 06/22/2018
• Report Date (Section F): 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2018
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1