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Driver’s Insulin Pump Blamed for Fatal Crash
By Jodine Mayberry
Medical Devices Litigation Reporter

A Warren County, Ky., man was killed in a motor vehicle collision after his insulin pump failed to deliver sufficient medication and he lost consciousness behind the wheel, according to a lawsuit filed in a Kentucky federal court.

Plaintiff Paula Kennedy, the administrator of Jeffrey T. Kennedy’s estate, alleges her husband was killed Feb. 17, 2004, when his Paradigm Sof-set Ultimate QR Infusion Set malfunctioned. The pump was attached to his abdomen and sent the insulin into his system subcutaneously.

The plaintiff says manufacturer Medtronic Inc. was preparing to issue a recall of a similar infusion set yet failed to advise or warn consumers, including Kennedy, of the impending recall. Medtronic had not filed an answer to the complaint at press time.

Medtronic recalled more than 160,000 Paradigm Quick-set Plus insulin pumps in June 2004 because the tube that delivers insulin to the body could become dislodged or disconnected, causing an interruption of the insulin flow.

The problem caused some 200 diabetics across the country to be hospitalized for elevated blood sugar levels, according an Associated Press report at the time.

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