Medical product manufacturer Medtronic announced that one of its insulin pumps could malfunction and deliver an insufficient dose of insulin or too much insulin. MedTechDive.com reported that Medtronic’s MiniMed 600 insulin pumps were manufactured with a fault that could give a patient hypoglycemia and hyperglycemia, both of which could result in severe if not fatal medical complications. Medtronic sent a warning letter to its customers warning about the problems associated with the MiniMed 600 insulin pump and indicated that the problem was traced back to a retainer ring on the device. Medtronic told its customers that they should inspect the integrity of the retainer rings to ensure that they are neither damaged nor missing.
Medtronic’s MiniMed 630G insulin pump model and the company’s MiniMed 670G are under scrutiny for a defect that could cause devastating health consequences if not repaired immediately. Medtronic said that the retainer ring that connects the reservoir to the pump could break is the pump was dropped. A missing or broken ring could cause the pump to malfunction and over-administer or under-administer insulin.
When the ring is broken or missing, the pump could infuse insulin rapidly, leading to hypoglycemia. Conversely, if there is a space between the reservoir and pump where the ring should be, the device could pump insulin more slowly, leading to a hyperglycemic condition for the patient.
As a result of these potential problems, Medtronic asked all of its customers to check the rings on their pumps to ensure that they are correctly working. Medtronic advised customers to stop using the pumps if there is a problem and obtain an immediate repair. Medtronic also suggested that users check the rings periodically to be sure that they are functioning properly.
Medtronic initiated two insulin pump recalls earlier in 2019. One recall was a Class II recall for its 600 series minipumps that experienced a keyboard problem. The company announced a Class I recall for one of its 500-series pumps because of a so-called cybersecurity problem.
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