MAUDE Adverse Event Report: ARKRAY FACTORY, INC. GLUCOCARD VITAL BLOOD GLUCOSE TEST SYSTEM

Model Number	761100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected. arkray was unable to contact the customer to gather more information or request the return of subject meter.Actual product was not returned for testing and lot number is not known so retention samples could not be tested. if either strips or meter is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Arkray usa, inc.Received the following complaint information via us mail.In approximately the (b)(6) of 2016, mr.(b)(6) obtained a new glycometer, glucocard vital serial number (b)(4).Customer claims that on or about the first week of (b)(6) 2017, the glycometer began giving inaccurate readings to mr.(b)(6).Customer also claims that on or about (b)(6) 2017, as a result of improper administration of glucose, the mr.(b)(6) became ill and was hospitalized at (b)(6) hospital in (b)(6).There he claims that he suffered a number of adverse symptoms and began to develop hallucinations.Mr.(b)(6) claims that he suffered these symptoms because he administered improper doses of insulin because of the failure of the glycometer manufactured by arkray usa, inc.To properly monitor his blood sugar levels as the glycometer was designed to do.We are unable to gather more information regarding this complaint because we do not have the customer's contact information.

• Brand Name: GLUCOCARD VITAL BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 8363145
• Report Number: 1832816-2019-00004
• Device Sequence Number: 11261316
• Product Code: NBW
• UDI-Device Identifier: 00015482760014
• UDI-Public: (01)00015482760014
• Combination Product (Y/N): N
• PMA/510(K) Number: K091102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 761100
• Device Catalogue Number: 761100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention