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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX BIOTECHNOLOGY CORP. GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
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APEX BIOTECHNOLOGY CORP. GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM Back to Search Results
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 09/18/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Arkray (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.
 
Event or Problem Description
Meter is reading in mmol/l instead of mg/dl.We did a blood test on the phone, and i did hear the meter say mmol/l.Will replace and will send a return label.She thinks she got the meter from (b)(6).
 
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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 Key9789864
Report Number9616936-2018-00004
Device Sequence Number2185256
Product Code NBW
UDI-Device Identifier00015482570101
UDI-Public(01)00015482570101
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K113098
Number of Events Summarized1
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 Lay User/Patient
Device Model Number571100
Device Catalogue Number571100
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/22/2018
Device Age5 YR
Event Location Other
Date Report to Manufacturer07/17/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2018
Initial Report FDA Received Date03/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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