Catalog Number 21-7230-24 |
Device Problems
Break (1069); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)
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Patient Problems
Hyperglycemia (1905); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Manufacturer Narrative
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Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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It was reported that a cleo® 90 infusion set was in use with a patient when an uncontrolled spike in blood glucose was observed.It was initially reported that the issue was observed after two days of device use but then it was reported that the site was removed due to the high blood glucose within 32 hours after initial placement and after more than 6 hours of "unresponsive [blood glucose] to insulin provided." the blood glucose was noted to have peaked around 400 mg/dl and a site change was conducted immediately.Upon site removal, it was observed that the infusion set tubing remained in the patient's body under her skin and lodged into the patient's tissue.It was suspected that the site breakage occurred prior to removal.It was noted that the site was placed and adhered normally after the area was thoroughly cleaned, skin tac applied, and allowed to dry.The patient was unable to remove the tubing on her own and experienced discomfort.The patient was taken to the emergency room for removal after two days from the incident.An unsuccessful attempt was made to remove the infusion set tubing.The patient was discharged with instruction to observe for infection and the discharge of the foreign body.The tubing remains in the patient's body and an appointment with an endocrinologist was made to consider an outpatient surgical removal.The event is considered ongoing.No permanent injury was reported.See mfr: 3012307300-2017-00191.
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Manufacturer Narrative
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The reporter returned a device for investigation.The device was not properly labelled prior to shipment and therefore was not properly identified at receiving.
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Event Description
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It was further reported that while at the emergency room, the patient received multiple numbing injections prior to the health professional's attempt to remove the infusion set cannula.The patient placed the cleo® 90 infusion set around their midsection (belly/abdomen and upper side area).According to the report, the cannula remains inside the patient and the patient's body was not dislodging the cannula.It was reported that the patient was advised that they will need to see a general or plastic surgeon to have the cannula removed.No information was provided regarding the potential date of the surgery.
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Search Alerts/Recalls
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