MAUDE report

MAUDE report 11110: ONE TOUCH II BLOOD GLUCOSE MONITOR

No Answer Provided · received Jan 26, 1994 · LIFESCAN, INC.

Key facts

MDR report key 11110
Report number MW4000076
Event type No Answer Provided
Brand name ONE TOUCH II BLOOD GLUCOSE MONITOR
Manufacturer LIFESCAN, INC.
Product code CFR
Device class Class II
Date received by FDA Jan 26, 1994
Report date May 27, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • No Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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