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	11/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) (importer) attempted to gather information and request the return of subject meter.Actual product was not returned for testing.Apex (manufacturer) did not receive the return of subject meter.The meter serial number provided is not correct, apex is not able to trace the manufacture date of the device.
Event or Problem Description
(b)(6) owns an expression (owned three years) and inquired: how do we change the units of blood glucose from mmol/l back to original mg/dl? he has taken the batteries out in hopes it would reset to factory default settings.He was able to find a conversion chart but that will become inconvenient.Meter had been reading in mg/dl as of friday, (b)(6) 2017, but then sometime before sunday, (b)(6) 2017, it started displaying results in mmol/l format.Customer reported that the meter has not been dropped or damaged in anyway.I asked the customer about the battery port and customer stated he did try changing the batteries to see if that would help.There was no corrosion or battery leakage evident in the battery port area.Customer was at work and did not have the meter with him to get the serial number.

• 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: 9789905
• Report Number: 9616936-2018-00006
• Device Sequence Number: 13999528
• 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: Replace
• 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: No Information
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2018
• 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