Silhouette® Paradigm® MMT-382Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05705244009165), received between Jan 2, 2019 and Mar 26, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT AT ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701133 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. ON 21 -AUG-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET TUBING DETACHEMENT THE SITE OF INSERTION WAS GLUTEOUS. THE INFUSION SET WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331085 ↗
• MalfunctionAug 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO ON 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCULSION IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113953 ↗
• MalfunctionAug 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO ON 31-JUL-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCULSION IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113952 ↗
• MalfunctionAug 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCULSION IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113950 ↗
• MalfunctionAug 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCLUSION IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113949 ↗
• MalfunctionAug 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCULSION IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113946 ↗
• MalfunctionAug 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCULSION IN TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113945 ↗
• MalfunctionAug 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON 18-JULY-2024 IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF INFUSION SET TUBING DETACHMENT. THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20060894 ↗
• MalfunctionApr 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2022, IT WAS REPORTED THAT WHILE THE PATIENT WAS WATCHING TELEVISION, THE INFUSION SET'S TUBING DETACHED FROM THE QUICK RELEASE AT THE SITE AND THE SITE WAS WET. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE RIGHT SIDE. MOREOVER, THE INFUSION HAD BEEN USED FOR THREE DAYS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14081226 ↗
• InjuryJun 17, 2019Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE WAS SLEEPING WHEN SHE WOKE UP EXPERIENCING HIGH BLOOD GLUCOSE LEVEL, NAUSEA, DIARRHEA, CHEST PAIN AS IF SHE WAS HAVING A HEART ATTACK, LABORED BREATHING, HIGH BLOOD PRESSURE AND VOMITING. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS HIGH THE WHOLE NIGHT THOUGH SHE HAD STOMACH INFECTION OR FOOD POISONING. AT THE TIME OF INCIDENT, BLOOD GLUCOSE LEVEL WAS AT 330 MG/DL, THEN 360 MG/DL AND BY THE TIME SHE GOT TO THE HOSPITAL, IT WAS 409 MG/DL. SHE WAS ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS WHERE SHE RECEIVED INSULIN DRIP. SHE STAYED IN THE INTENSIVE CARE UNIT FOR THREE DAYS BECAUSE SHE DID NOT KNOW THAT THE INFUSION SET WAS LEAKING FROM THE TUBING AT THE TOP OF TUBING CONNECTOR, WHICH CONNECTS TO THE RESERVOIR. THE TUBING DID NOT DETACH AND THE PUMP WAS NOT DROPPED WITH THE SET IN PLACE. AT THE TIME OF THIS REPORT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 144 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8702711 ↗
• MalfunctionMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT IN ONE OF THE INFUSION SETS, THE TUBE OF THE CANNULA SIDE PART, WHICH WAS INSERTED UNDER THE SKIN CAME OFF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635090 ↗
• MalfunctionApr 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HE HAD A DETACHED TUBING AT THE SITE WHILE KICKING BACK, PLAYING VIDEO GAMES AND TAKING A NAP THAT LED UP TO HIGH BLOOD GLUCOSE LEVEL. HIS BLOOD GLUCOSE LEVEL WAS 340 MG/DL AT THE TIME OF INCIDENT AND HE HAD SYMPTOMS LIKE VOMITING WHICH HE TRIED TO TREAT WITH A PUMP. THE SITE LOCATION WAS AT THE RIGHT ABDOMEN AND THE PUMP WAS LOCATED AT THE RIGHT ABDOMEN. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. THE PATIENT WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND BLOOD GLUCOSE LEVEL WAS 340 MG/DL AT THE TIME OF HOSPITALIZATION. THE PATIENT WORE THE PUMP THE ENTIRE TIME HE WAS HOSPITALIZED AND RECEIVED SEVERAL X-RAYS AND WAS IN A CAT SCAN WHILE WEARING THE PUMP. REPORTEDLY, THE INFUSIONS WERE STORED IN A COOL DRY PLACE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. HE WAS HOSPITALIZED FOR 2 DAYS AND WAS STABLE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8563392 ↗
• InjuryApr 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT ONE OF THE INFUSIONS SET BROKE OFF IN THE PATIENT'S BODY DURING USE AND HAD TO OPERATE TO GET IT REMOVED FROM THE BODY BECAUSE IT WAS FLOATING AROUND IN THE BODY. THE SET INSERTION LOCATION WAS AT THE RIGHT SIDE OF ABDOMEN, BELOW BREAST, BETWEEN BREAST AND WAISTLINE. THE INFUSION HAD BEEN IN USE FOR ABOUT 6 MONTHS. SHE HAD PAIN AT THE SITE SINCE THEN, SO SHE WENT TO HER HEALTH CARE PROFESSIONAL AND HE DID AN X-RAY AND FOUND THE CANNULA WAS STILL INSIDE HER BODY. SHE INSERTED THE SET IT STUNG AFTER REMOVING INTRODUCER NEEDLE, BUT SITE SEEMED OKAY BUT WHEN SHE WENT TO REMOVE THE SET 3 DAYS LATER IT BLEEDS. AT THE TIME OF THIS REPORT, SHE WAS WAITING FOR HER SURGEON TO CALL BACK WITH A SURGERY DATE TO HAVE CANNULA SURGICALLY REMOVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 8538581 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHILE THE PATIENT WENT OUT TO EAT LAST EVENING AND HUNG THE INFUSION SET ON POCKET LIKE NORMALLY, THE INFUSION SET'S TUBING LEAKED FROM WHERE THE TUBING CONNECTS TO TUBING CONNECTOR. REPORTEDLY, HER MOUTH WAS REALLY DRY, AND HER BLOOD GLUCOSE WAS 300 MG/DL AT THAT POINT AND SHE EXPERIENCED MILD DIABETIC KETOACIDOSIS. SHE TOOK AN ADDITIONAL UNIT AND THE BLOOD GLUCOSE WENT UP TO 400 MG/DL. SINCE HER BLOOD GLUCOSE DID NOT WENT DOWN AND SHE DID NOT SAW ANY LEAK, SO SHE DISCONNECTED THE TUBING FROM THE BODY AND PUT FILL CANNULA THROUGH IT TO SEE WHETHER INSULIN CAME THROUGH. HOWEVER, NO INSULIN CAME THROUGH, SHE TRIED FEW TIMES AND DID NOT SAW INSULIN BUT WHEN SHE LOOKED UNDER THE TUBING IT WAS WET HAD BEEN LEAKING. REPORTEDLY, SHE FELT LIKE SHE COULD SEE A COMPROMISE IN THE TUBING AT A SPOT. THIS ISSUE HAPPENED EARLIER ABOUT A FEW WEEKS AGO. THE SITE LOCATION WAS RIGHT SIDE, BELOW THE NAVEL AND THE PUMP WAS ON THE LEFT SIDE, SITE WAS BELOW THE NAVEL. THE INFUSION WAS USED FOR AROUND 30 HOURS. THE INFUSIONS WERE STORED IN A WARDROBE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP W

  Patient problems: Hyperglycemia

  MAUDE report 8481420 ↗
• MalfunctionApr 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHEN HE WOKE UP, HE NOTICED THAT TUBING DETACHED. THE SITE LOCATION WAS AT THE RIGHT THIGH. THE INFUSION HAD BEEN IN USE FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE IF THERE WAS STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8472329 ↗
• MalfunctionJan 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED, WHEN SHE SLEPT LAST NIGHT, THE TUBING WAS LOOSE FROM THE SET. THE AREA WHERE THE SET BECAME DETACHED WAS THE SECOND CONNECTOR AND NOT THE SITE. REPORTEDLY, THE PATIENT WOKE UP IN THE MORNING AND THE INFUSION SET HAD BROKEN AWAY FROM THE SET. THE PATIENT REPORTED INFUSION SET TUBING CAME APART. REPORTEDLY, THE PATIENT WAS USING THE INFUSION FOR 4 DAYS. THE PATIENT WAS NOT SURE ABOUT THE STRESS OR PULL ON THE TUBING, HOWEVER, THE PUMP WASN'T DROPPED WITH THE SET CONNECTED TO THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211197 ↗