MAUDE report

MAUDE report 44085: GLUCOMETER 4 ENCORE MMOL/L (EX US ONLY)

Malfunction · received Oct 16, 1996 · BAYER CORPORATION

Key facts

MDR report key 44085
Report number 1810909-1996-00005
Event type Malfunction
Brand name GLUCOMETER 4 ENCORE MMOL/L (EX US ONLY)
Model number 5886
Catalog number 5886
Manufacturer BAYER CORPORATION
Product code CFR
Device class Class II
Date received by FDA Oct 16, 1996
Report date Oct 10, 1996
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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