Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; System, test, blood glucose, over the counter
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

; System, test, blood glucose, over the counter Back to Search Results
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The user has not yet provided the nonconforming meter or related information.Therefore, this case will be temporarily closed.If we receive the meter or related information from the user in the future, the analysis will be restarted.The user has not yet provided the nonconforming meter or related information.The fields for lot or batch number, serial number, and manufacturing date cannot be filled in.If the user provides the relevant information later, it will be filled in accordingly.
 
Event or Problem Description
This submission is a follow-up report for mfr report number: 3004130086-2024-00016 (file name: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Common Device Name
System, test, blood glucose, over the counter
MDR Report Key21982853
Report Number3004130086-2025-00007
Device Sequence Number17262863
Product Code NBW
UDI-Device Identifier00885017000058
UDI-Public00885017000058
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/08/2025
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? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/08/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Patient Sequence Number1
Patient SexUnknown
-
-