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	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Products involved in incident (glucocard expression meter (serial no.: (b)(4)) and returned strips (lot no.: b4s1903003)) were returned for evaluation to arkray (importer and complaint handler).Meter, returned strips and retain strips performed to specification.No failures detected.Evidence are attached with file name "arkray evaluation (meter - el573427)".Apex (manufacturer) performed evaluation to specification with retain meter of the same batch and retain strips of the same batch.No failures detected.Evidence are attached with file name "apex evaluation (retain meter & retain strips)".
Event or Problem Description
Customer called because his wife was receiving variances when performing a blood test.The readings she received were around lunch time.She stated the reading was lo, then a few minutes later received 302, then again received 289.These readings were in b & c zones per parkes grid.Customer stated that each reading was one minute a part.El573427.Lot b4s1903003 - 2020-12-05 - 50ct.Opened test strips about a month or less ago.Customer is not receiving any oxygen therapy.Caller doesn't have trouble getting a sample of blood but one time a week she'll get an error message that there's not enough blood.Washes her hands with soap and water.She also uses alcohol wipes.Caller doesn't change the lancets every time she tests.She stores in the dining room about 20 feet from the kitchen and there's a divider between the rooms.Seals bottle cap tightly and immediately after removing a strip.Customer doesn't have control solution.She uses fingertip as a testing site.I walked the customer through a blood test, and she received a reading of 276.Replaced meter, strips and sent return label.

• Brand Name: GLUCOCARD EXPRESSION BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: GLUCOCARD EXPRESSION 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: 9762042
• Report Number: 9616936-2019-00001
• Device Sequence Number: 713444
• Product Code: NBW
• UDI-Device Identifier: 00015482570057
• UDI-Public: (01)00015482570101,(01)00015482570057
• 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
• Type of Report: Initial
• Report Date (Section B): 11/20/2019
• Report Date (Section F): 12/06/2019

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: 12/05/2020
• Device Model Number: 571100
• Device Catalogue Number: 571100
• Device Lot Number: B4S1903003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 9 MO
• Event Location: Other
• Date Report to Manufacturer: 12/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 116