MiniMed® 530G MMT-751NAL (UDI 00643169736085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00643169736085), received between Sep 15, 2017 and Jul 15, 2020 — classified as 1 death, 29 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (P120010); they may or may not involve this specific model.

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.

Recalls naming this device

1. Feb 13, 2026Class IIOpen, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1751-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S SCREEN WAS HARD TO SEE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10274864 ↗
• MalfunctionJul 14, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP ALARMED MOTOR ERROR AND INSULIN PUMP WAS NOT WORKING. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER WAS ABLE TO CLEAR AND ABLE TO REWIND INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10270547 ↗
• MalfunctionJun 4, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN HARDER TO SEE. THE CUSTOMER STATED THEY THE INSULIN PUMP HAD CRACK ON RESERVOIR COMPARTMENT, PRIMING TAKING LONGER TO COMPLETED AND UNEXPLAINED NO DELIVERY ALARMS. CUSTOMER REPORTED THAT THE BATTERY WAS LESS THEN 7 DAYS, BUTTON HAD TO BE PRESSED HARDER TO WORK DURING PRIMING AND RAINBOW EFFECT ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118069 ↗
• MalfunctionApr 8, 2020Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WOULD SQUIRT OUT INSULIN WHILE PRIMING. THE BLOOD GLUCOSE LEVELS WERE 136 MG/DL. CUSTOMER ALSO MENTIONED PRIME LOOP. TROUBLESHOOTING WAS PROVIDED. IT WAS STATED THAT THE RESERVOIR RING WAS DAMAGED AND THAT THE RESERVOIR LOCKED IN LOOSELY. ISSUE WITH PRIME LOOP WAS NOT FIXED. THE INSULIN PUMP WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937491 ↗
• MalfunctionMar 4, 2020Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE HARDER TO PRESS. CUSTOMER STATED SOMETIMES FLASHLIGHT BUTTON WON'T COME THE FIRST TIME IT'S PRESSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9785055 ↗
• InjuryJan 19, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 485 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS 450 MG/DL AND 460 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. CUSTOMER STATED THAT MOTOR DID NOT PUSH OUT INSULIN WHEN BLOUSING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9605024 ↗
• MalfunctionOct 28, 2019No Display/Image; Battery Problem; Insufficient Device Problem Information; No Display/Image; Battery Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP GETS AN ERROR MESSAGES AND GOES TO A BLACK SCREEN AND BATTERY LIFE HAD DECLINED OVER TIME OF USE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER DECLINED HELPLINE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247605 ↗
• MalfunctionOct 3, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT THE ESC BUTTON WAS HARD TO RESPOND. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE TIME WAS ADVANCING. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOISTURE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND INSULIN WAS EXITED. CUSTOMER STATED THAT THE CANNULA WAS NOT BENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150210 ↗
• MalfunctionOct 1, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BOLUS BUTTON STICKING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138417 ↗
• InjuryJun 27, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER WOKE UP WITH BLOOD GLUCOSE LEVEL OF 500 MG/DL. THE CUSTOMER'S HIGH BLOOD GLUCOSE WAS TREATED WITH BOLUS. IT WAS ALSO CUSTOMER REPORTED PAST EVENT THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARM AND ALARM DID NOT OCCUR DURING MANUAL PRIME. THE CUSTOMER WAS NOT ABLE TO TROUBLESHOOT AT TIME OF CALL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8738463 ↗
• InjuryMay 28, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER¿S REPORT CUSTOMER DOES NOT ALLEGE UNDER DELIVERY. THE CUSTOMER WAS WEARING THE INSULIN PUMP WHEN HIGH BLOOD GLUCOSE EVENT WAS REPORTED. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM IN THE PAST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8645027 ↗
• MalfunctionApr 16, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP BUTTONS WERE NOT WORKING ANYMORE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 224 MG/DL. THE CUSTOMER REPORTED THAT THE UP ARROW BUTTON WAS NOT WORKING. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517035 ↗
• MalfunctionMar 28, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS OVER DELIVERING INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THE PUMP WAS ALSO PRODUCING SUGGESTIVE BOLUSES OF 2 TO 3 UNITS AS IT NORMALLY DOES. NO CHANGES WERE MADE TO THE PUMP SETTINGS. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458806 ↗
• MalfunctionMar 27, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM AND NO DELIVERY. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455293 ↗
• InjuryFeb 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8352296 ↗
• InjuryJan 16, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED THE HIGH BLOOD GLUCOSE AND THE INSULIN PUMP WAS HAVING THE KEYPAD ISSUE. THE CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL, 484 MG/DL. THE CUSTOMER REPORTED THAT KEYS WERE MESSING UP AND HARD TO USE. ONLY THE B BUTTON WORKS FINE, THE REST WERE HARD TO USE AND SLOW TO RESPOND. THE CUSTOMER REPORTED THAT THE INSULIN HE PUMP WAS NOT WORKING. THE TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN AND THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8252038 ↗
• MalfunctionNov 26, 2018Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND PRIME ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE ACT BUTTON DURING PRIMING STOPPED WORKING AND HAD TO PRESS MULTIPLE TIMES TO RESPOND. IT WAS REPORTED THAT THE PUMP SCREEN HAD SCRATCHES ON THE DISPLAY THAT EFFECTED THE ABILITY TO SEE SCREEN FULLY. IT WAS REPORTED THAT THEY HAD TO REWIND TWICE DURING PRIMING OF THE PUMP. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8103662 ↗
• InjuryNov 23, 2018Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 200 MG/DL, 300 MG/DL, 328 MG/DL, 411 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 349 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT REPORT ANY SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8100048 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMERS REPORTED VIA PHONE CALL THAT THE THEY WERE HOSPITALIZED DUE TO HYPERGLYCEMIA AS WELL AS DIABETIC KETOACIDOSIS ON (B)(6) 2018 WITH BLOOD GLUCOSE VALUE OF 700MG/DL. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 526MG/DL AT THE TIME OF INCIDENCE AND CURRENT BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE VALUE. CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTS THEY DID CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING OR IN RESERVOIR. ASSISTED CUSTOMER WITH PERFORMING THE HIGH PERFORMANCE TEST AND TEST WAS PASSED. ADVISED CUSTOMER TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR; UNOMED INF SET.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8076899 ↗
• MalfunctionNov 2, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN THAT AFFECT TO READ THE INSULIN PUMP. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8031889 ↗
• MalfunctionNov 2, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 250 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS DURING BASAL AND BOLUS. CUSTOMER ASSISTED TO PERFORM A 5.0 UNIT FIXED PRIME. CUSTOMER STATES THE INSULIN DID NOT EXIT AND INSULIN PUMP ALARMED NO DELIVERY. ADVISE TO REMAIN DISCONNECT AND PUSH INSULIN SLOWLY THROUGH THE TUBING. CUSTOMER REPORTS INSULIN DID NOT EXIT AND THERE WAS GREATER THAN NORMAL RESISTANCE WITH PLUNGER PUSH. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8031807 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED AT AN UNKNOWN TIME DUE TO A HIGH BLOOD GLUCOSE EXCEEDING 600 MG/DL. THE PATIENT WAS TREATED IN THE INTENSIVE CARE UNIT WITH INTRAVENOUS FLUIDS. THE CUSTOMER WAS WEARING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE HOSPITALIZATION. THE CUSTOMER HAD A BENT INFUSION SET CANNULA AT THE TIME. TROUBLESHOOTING WAS DECLINED FOR THE HIGH BLOOD GLUCOSE. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 7921514 ↗
• DeathSep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2018. THE CAUSE OF DEATH WAS UNKNOWN. THE CALLER STATED THAT THE CUSTOMER¿S NEUROPATHY MAY HAVE LED TO THEIR PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER USED SENSORS. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 7895427 ↗
• MalfunctionAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT THE CUSTOMER VISITED THE HOSPITAL DUE TO A HIGH BLOOD GLUCOSE OF 500 MG/DL. THE NURSE WAS CALLING TO MAKE SURE THAT THE INSULIN PUMP DID NOT MALFUNCTION. TROUBLESHOOTING WAS NOT COMPLETED DURING THE PHONE CALL. THE NURSE WAS TOLD THAT A MEDTRONIC DIABETES TRAINER WOULD BE INFORMED ABOUT THE EVENT AND INSTRUCTED TO CONTACT THE NURSE. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7816956 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED NO DELIVERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 440 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPLACE THE SET AND MENTION THE NO DELIVERY ALARM WAS A PAST ALARM AND PUMP DID NOT ALARM NO DELIVERY WITH CURRENT SET. THE INSULIN PUMP IS NOT BEING REPLACED AND IS NOT EXPECTED TO RETURN FOR ANALYSIS. FRN-MODEL UNKNOWN ¿ RESERVOIR. UNOMEDICAL-MODEL UNKNOWN-INFUSION SET.

  Patient problems: Hyperglycemia

  MAUDE report 7816720 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.

• Z-2544-2014 · Mar 13, 2014 · Terminated
  Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K