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MiniMed® 530G MMT-751NAP (UDI 00643169736092)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-751NAP PRDGM V3.0 PL EN 1PRESS · Class 3

All models of MiniMed 530G (71)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This is a Medtronic MiniMed 530G insulin pump, a wearable artificial pancreas system that continuously delivers insulin. The 29 reports mostly describe pumps that stop or fail to prime and rewind, showing error codes, blank or hard-to-read screens, dead batteries, and buttons that stick or stop responding, sometimes alongside high blood sugar and vomiting. Nine reports describe injuries and there are no deaths. One recall, opened in February 2026, covers unintended over- or under-delivery of insulin when the pump's position changes relative to the infusion site.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
29
Deaths reported
0
Injuries reported
9
Recalls naming it
1

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169736092), received between Oct 18, 2017 and Jul 8, 2020 — classified as 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (6 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

Device problems

  • Device Difficult to Program or Calibrate6
  • Mechanical Problem6
  • No Display/Image4
  • Power Problem4
  • Battery Problem3
  • Device Displays Incorrect Message3
  • Patient Device Interaction Problem3
  • Priming Problem3

Patient problems

  • No Consequences Or Impact To Patient17
  • Hyperglycemia10
  • Dyspnea2
  • Hypoglycemia2
  • Nausea2
  • Vomiting2
  • Abdominal Pain1
  • Headache1

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 8, 2020Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S SCREEN WAS SCRATCHED AND DIFFICULT TO SEE. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES, AND GRINDS DURING REWIND. 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 10243423 ↗
  • MalfunctionJan 13, 2020Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 314 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS UNABLE TO SUCCESSFULLY CLEAR THE ALARM. THE CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWOUND. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9579830 ↗
  • InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED BECAUSE OF HEADACHE DUE TO HIGH BLOOD GLUCOSE ON JANUARY 2 WITH BLOOD GLUCOSE OF 861 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS DRIP IN THE HOSPITAL. CUSTOMER EXPERIENCED SYMPTOM SUCH AS NAUSEA, VOMITING, ABDOMINAL PAIN AND DIFFICULTY IN BREATHING. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. CUSTOMER REPORTED THEY DID CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER PERFORMED HIGH PRESSURE TEST AND IT WAS FAILED HOWEVER REPEATED TEST PERFORMED AND IT WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Abdominal Pain; Dyspnea; Headache; Hyperglycemia; Nausea; Vomiting

    MAUDE report 9567312 ↗
  • MalfunctionDec 18, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Priming Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP'S BUTTON WAS UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED CUSTOMER HAS TO TAKE OUT BATTERY AND RESET THE SETTINGS FOR THE INSULIN PUMP TO WORK, PRIME AND REWIND PROCESS TOOK LONGER AS WELL AS INSULIN PUMP WAS LOUDER DURING THE PRIME OR REWIND PROCESS. CUSTOMER MENTIONED THAT RECEIVED NO DELIVERY AND DIMINISHED BATTERY LIFE SO HAS TO CHANGE BATTERY EVERY WEEK. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9488172 ↗
  • MalfunctionNov 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD E CODE ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THEY HAD ISSUE WITH BELT CLIP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9388331 ↗
  • MalfunctionNov 26, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE STICK. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD HIGH PITCHED WHEN REWIND SOMETIMES AND SQUIRTING WHEN PRIMING. CUSTOMER STATED INSULIN PUMP REJECT BRAND NEW BATTERY. CUSTOMER DECLINED 24 HOUR HELPLINE SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9374460 ↗
  • InjuryOct 25, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA ON (B)(6) 2019 WITH BLOOD GLUCOSE LEVEL OF 600 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER EXPERIENCED THE SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE WAS NAUSEA, VOMITING, DIFFICULTY IN BREATHING. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THAT DRIVE SUPPORT CAP APPEARED NORMAL. DISPLACEMENT TEST WAS PASSED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Dyspnea; Hyperglycemia; Nausea; Vomiting

    MAUDE report 9236852 ↗
  • MalfunctionOct 16, 2019Failure to Cycle; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem; Failure to Cycle; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SHOOT INSULIN OUT FROM CANNULA AND LOOSING MORE THAN 2 TO 3 DROPS DURING PRIME. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER REPORTED CHIPPED AROUND BATTERY HOUSING, BATTERIES LASTING LESS THAN 7 DAYS, INSULIN PUMP TAKING LONGER TO PRIME AND MOTOR GETTING LOUDER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9196238 ↗
  • InjurySep 17, 2019Power Problem; Power Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 898 MG/DL AND WENT TO HOSPITAL. CUSTOMER STATED THAT INSULIN PUMP HAD LOW BATTERY LIFE. CUSTOMER DECLINED TROUBLESHOOT FOR THE INSULIN PUMP. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9077470 ↗
  • MalfunctionAug 23, 2019Intermittent Communication Failure; Intermittent Communication Failure

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD WATCHDOG TIMEOUT ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 125 MG/DL. CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ASSISTED IN PERFORMING A SELF TEST AND THE TEST WAS PASSED. CUSTOMER TOOK OUT THE BATTERY AND PUT THE SAME BATTERY IN RESULTING IN A BLACK CIRCLE AND NOT ABLE TO HIT SELF TEST HAD CUSTOMER CHANGE OUT BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8924935 ↗
  • MalfunctionAug 16, 2019No Display/Image; Battery Problem; Loss of Data; No Display/Image; Battery Problem; Loss of Data

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARM EXTERNAL FLASH ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND ALSO HAD TO CHANGE BATTERY MORE FREQUENTLY. THE CUSTOMER REPORTED SCREEN WENT BLANK AND THEN CAME BACK ON. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8900442 ↗
  • MalfunctionAug 1, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS HARD TO PRESS AND IT NEEDED TO CONTINUE PRESSING FOR IT TO RESPOND. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO HIGH ALTITUDE FOR 4 DAYS. THE CUSTOMER REPORTED THAT THE TIME ADVANCED ON THE INSULIN PUMP. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8851405 ↗
  • MalfunctionMar 27, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE STICKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 195 MG/DL. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8455166 ↗
  • MalfunctionMar 25, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS A CRACK AT THE RESERVOIR AREA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER STATES THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURN FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8447326 ↗
  • MalfunctionMar 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS HARD TO PUSH. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8442806 ↗
  • MalfunctionDec 20, 2018No Display/Image; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; No Display/Image; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE. THE CUSTOMER WAS USING AN OLD INSULIN PUMP THAT SHE GOT THE BUTTON ERROR ON. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR FLUID EXPOSURE. THE CUSTOMER REPORTED THAT THE BUTTONS STOPPED WORKING THE NEXT DAY AND THE SCREEN WENT BLANK. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE CUSTOMER WAS ADVISED THE PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8184178 ↗
  • InjuryNov 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 408 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S OTHER RELEVANT BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER STATED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. INSULIN DELIVERY WAS NOT SUSPENDED DUE TO SENSOR GLUCOSE VALUES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8036112 ↗
  • InjuryOct 24, 2018No Apparent Adverse Event; No Apparent Adverse Event

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 423 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7999015 ↗
  • MalfunctionOct 9, 2018Device Alarm System; Device Alarm System

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REWIND, AUDIO AND PRIME ANOMALIES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE REWIND TOOK LONGER, LOUDER SOUND WHEN REWINDS AND PRIMES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7946520 ↗
  • MalfunctionJul 19, 2018No Display/Image; No Display/Image

    CUSTOMER REPORTED VIA PHONE CALL BLANK DISPLAY ANOMALY ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 262 MG/DL. TROUBLESHOOTING FOR BLANK DISPLAY WAS PERFORMED. CUSTOMER ADVISED THEY CHANGED THE BATTERY AND THE BATTERY CAP HOWEVER THE INSULIN PUMP REMAINED BLANK. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7705286 ↗
  • MalfunctionJul 17, 2018Power Problem; Power Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP REJECTED NEW BATTERY, IT WAS SLOWER DURING REWIND AND MOTOR WAS MAKING SOUND AND INSULIN PUMP HAD A NO DELIVERY ALARMS. THE BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7693325 ↗
  • MalfunctionApr 12, 2018No Display/Image

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS 134 MG/DL AT THE TIME OF THE INCIDENT. ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7424436 ↗
  • InjuryJan 22, 2018Device Displays Incorrect Message

    CUSTOMER REPORTED VIA PHONE CALL FOR HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE WAS 453 MG/DL. CUSTOMER STATED THAT SHE HAS A LOW BATTERY ALARM AND HAS BEEN TRYING TO GET THE BATTERY CAP UNSCREWED AND CANT. CUSTOMER STATED THAT SHE HAS BEEN TRYING FOR AT LEAST 8 HOURS AND CAN¿T GET ANYTHING OPEN. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING AS SHE KNOWS WHY HER HIGH HAPPENED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7210797 ↗
  • MalfunctionDec 28, 2017Insufficient Flow or Under Infusion

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 310 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 139 MG/DL. THE CUSTOMER TREATED WITH MANUAL INJECTIONS. CUSTOMER WAS ALLEGING POSSIBLE PUMP UNDER DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7152156 ↗
  • InjuryDec 19, 2017Device Alarm System

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PATIENT HAD LOW BLOOD GLUCOSE. THE CUSTOMER REPORTED THAT SHE HAD A LOW BLOOD SUGAR OF 43 MG/DL. CUSTOMER STATED THAT HER INSULIN PUMP DID NOT ALARM THAT HER BLOOD SUGAR WAS LOW. CUSTOMER STATED SHE DOESN'T WANT TO TROUBLE SHOOT FOR LOW BLOOD SUGAR AND WANTS TO LOOK AT INSULIN PUMP BECAUSE IT DIDN'T ALARM. CUSTOMER ISN'T ABLE TO UPLOAD AT TIME OF CALL AND STATED SHE WILL CALL BACK WHEN SHE CAN UPLOAD TO CARE LINK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 7130187 ↗

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

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Sources and updates

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