Medline · METER, GLUCOSE, HARMONY,PROF.USE ONLY
Medline Industries, LP · Electrical /Electronic Property Problem
- Manufacturer contact zip ext
- -275
- Report to FDA
- N
- Manufacturer contact state
- IL
- Manufacturer link flag
- Y
- Manufacturer contact address 1
- Three Lakes Drive
- Event type
- Malfunction
- Report number
- 1417592-2026-53966
- Product problem flag
- Y
- Date received
- 20260930
- PMA pmn number
- K161299
- Date of event
- 20260904
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 60093
- Noe summarized
- 1
- Manufacturer contact l name
- Anwar
- Reporter country code
- US
- Date added
- 20260930
- Manufacturer contact f name
- Muniba
- Device date of manufacturer
- 20240601
- Reporter state code
- TN
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260929
- Initial report to FDA
- No
- Manufacturer g1 country
- US
- Manufacturer contact city
- Northfield
- MDR report key
- 50941446
- Date manufacturer received
- 20260904
- Report source code
- Manufacturer report
- Adverse event flag
- N
- Single use flag
- N
- Manufacturer contact postal code
- 60093-2753
- Type of report
- Initial submission
- Source type
- Company representation
- Device
- Device sequence number
- 319555
- Date received
- 20260930
- Brand name
- Medline
- Generic name
- METER, GLUCOSE, HARMONY,PROF.USE ONLY
- Manufacturer d name
- Medline Industries, LP
- Manufacturer d address 1
- Three Lakes Drive
- Manufacturer d city
- Northfield,
- Manufacturer d state
- IL
- Manufacturer d zip code
- 60093
- Manufacturer d zip code ext
- -275
- Manufacturer d country
- US
- Manufacturer d postal code
- 60093-2753
- Catalog number
- MPH6540
- Device availability
- Yes
- Date returned to manufacturer
- 20260914
- Device report product code
- NBW
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 10888277675674
- UDI public
- 10888277675674
- Harmonized identifiers (openFDA)
- Device name
- System, Test, Blood Glucose, Over The Counter
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1345
- Device class
- 2
- Product problems
- Electrical /Electronic Property Problem
- Patient
- Patient sequence number
- 1
- Date received
- 20260930
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions