ClearanceBrief
Recall Z-0010-05 ยท LZG Pump, Infusion, Insulin

Medtronic MiniMed

Medtronic MiniMed Paradigm Model 712

DateSep 14, 2004
StatusTerminated
ReasonSeveral complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
Root causeOther
Quantity10,600
DistributionNationwide & Spain
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030531MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
Minimed, Inc., Jun 17, 2003