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

Model Number	571100
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product involved in incident was not returned for evaluation.Retention samples of the same lot of test strips involved in the incident were tested and performed to specification.
Event or Problem Description
Customer stated that she tested on the meter and received variances.She stated that she received the following results: (b)(6).The back to back readings of 20 and 114 are an 82.5% variance in zone c.There was no adverse event.Patient did not treat herself based on readings and re-tested to ensure she was receiving the correct readings.Caller stated that patient is not receiving oxygen therapy, uses fingertip for testing, no trouble getting a sample of blood, changes lancets every time she tests.Normal glucose readings are 124-162.Washes hands with soap and water then allows to dry completely, then cleanses finger with alcohol as well and allows it to dry.She stores meter and strips in her bedroom.Seals bottle cap tightly and immediately after removing test strip.Opened test strips about one month ago.No controls were used as caller does not have control solution.Replaced meter, test strips, and sent return label.
Additional Manufacturer Narrative
Meter involved in incident was returned.Meter was evaluated with retain strips and performed to specification.No failure detected.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): APEX BIOTECHNOLOGY CORP.; no. 7 ii-hsin road v; hsinchu science park; hsinchu, taiwan 30078, ; TW
• MDR Report Key: 7231283
• Report Number: 1832816-2018-00002
• Device Sequence Number: 1447939
• Product Code: NBW
• UDI-Device Identifier: 00015482570101
• UDI-Public: (01)00015482570101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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 Expiration Date: 01/05/2019
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S1704006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 94