MAUDE Adverse Event Report: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; BLOOD GLUCOSE METER

Model Number	44933
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to nova and no serial number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.The instructions for use (ifu) state: "warning: do not stare into the laser light or point it towards anyone's eyes while scanning a barcode." multiple attempts were made to obtain additional information, however; there was no response.This complaint will be closed as 'no complaint sample returned to nova for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.
Event or Problem Description
Customer called to inquire about any dangers imposed by the beam of the barcode scanner in statstrip glucose hospital meter pn 44993.A user looked into the scanner of a statstrip meter.Customer reported their eyes hurt and started seeing black shapes.Customer went to see the hospital's medical officer to report the event and seek consultation.Multiple attempts were made to receive specific results and or patient specific information, however; no further information has been provided by the facility.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUCOSE METER
• MDR Report Key: 10267424
• Report Number: 1219029-2020-00040
• Device Sequence Number: 19487200
• Product Code: PZI
• UDI-Device Identifier: 00385480449939
• UDI-Public: 00385480449939
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: Health Professional
• Device Model Number: 44933
• Device Catalogue Number: 44993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1