BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 13853772 · Received March 22, 2022

    Report

    Report Number
    2032227-2022-169786
    Event Type
    Injury
    Date Received
    March 22, 2022
    Date of Event
    March 13, 2022
    Report Date
    April 10, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED POSSIBLE OVER DELIVERY, EMS DISPATCHED AND WAS HOSPITALIZED FOR LOW BGS FOUND ON MARCH 13, 2022. DEVICE PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08745 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF MARCH 13, 2022, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND BOLUS DELIVERIES OF DAILYTOTALOFBOLUSINSULINDELIVERED = (B)(4) U BOLUS. 03/13/2022 08:04:44.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 3 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 12:33:16.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 6.5 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 14:46:40.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 8.6 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 16:22:24.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 10.5 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 16:56:38.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 16 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 17:13:32.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 17.1 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 19:25:44.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 18 BOLUSAMOUNTDELIVERED = (B)(4) 03/13/2022 22:18:06.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 4.5 BOLUSAMOUNTDELIVERED = (B)(4). ON 03/13/2022 22:18:06.000, A BOLUS DELIVERY OF (4.5 U) WAS CANCELLED BY THE USER AND THE BOLUS AMOUNT DELIVERED WAS ((B)(4)). DEVICE WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. DEVICE PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS. CUSTOMER ALLEGED FOR POSSIBLE OVER DELIVERY WAS NOT CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER DID ALLEGE INSULIN PUMP WAS OVER DELIVERING. NO FURTHER COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517300 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG5NBGL 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization FRN-UNK-RSVR, UNOMED INF SET