MAUDE Adverse Event Report: MEDTRONIC MINIMED PRDGM INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-XXX

Device Problems Air Leak (1008); Break (1069); No Display/Image (1183); Difficult to Insert (1316); Leak/Splash (1354); Moisture Damage (1405); Component Missing (2306); Patient-Device Incompatibility (2682); Battery Problem (2885)

Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Unspecified Infection (1930); Irritation (1941); Pain (1994); Scarring (2061); Diabetic Ketoacidosis (2364); Blood Loss (2597)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

In the study, ¿insulin pump-associated adverse events are common, but not associated with glycemic control, socioeconomic status, nor pump/ infusion set type¿, 174 adults and children within new zealand participated in a questionnaire examining pump-related issues they had experienced in the preceding 12 months.In table 1 of the article, the data shows that 22 of the 174 surveyed patients used medtronic insulin pumps.The 9 children and 13 adults on medtronic devices used a full spectrum of the products, ranging from the x54 veo insulin pumps to the paradigm series insulin pumps.The types of infusion sets used by the medtronic customers included the paradigm quick-set, paradigm silhouette, and paradigm mio.Of the 174 study participants (22 of which were using medtronic devices), 66 subjects reported device malfunctions including, mechanical/electronic malfunctions 31/66 (47%), physical damage 19/66 (29%), battery related 10/66 (15%), screen fade 10/66 (10%), keypad problems 6/66 (9%), water damage 5/66 (8%), leaking insulin 4/66 (6%), and lost/missing hardware 2/66 (3%).Infusion set/site related adverse events could also be further subcategorized in 41/74 subjects, with no additional information available in those remaining.In order of reported frequency: complete failure 17/41 (41%), infusion set damage 8/41 (20%), insertion failure 7/41 (17%), adhesive failure 6/41 (15%), pain 1/41 (2%), recurrent air bubbles 1/41 (2%), and obvious manufacturing fault prior to insertion 1/41 (2%).In a similar manner, all cutaneous adverse events were subcategorized, in order of reported frequency: skin irritation/reactions 54/74 (73%), scarring 36/74 (49%), infection 30/74 (41%), bleeding/bruising 4/74 (5%), lipohypertrophy 2/74 (3%), and lipoatrophy 1/74 (1%).An event serious enough to require a hospital presentation occurred in 9.8%, all but one reporting high ketones or diabetic ketoacidosis (dka).The article concludes that insulin pump-associated adverse events appear common and should therefore be anticipated.However, few variables are predictive of them with no relationships seen with glycaemic control, socioeconomic status, pump manufacturer nor infusion set type.Based on these findings, adverse events should be anticipated in both adults and children, with anticipatory patient education and training recommended for their successful and safe use.Individual events were not recorded in this study.No products were returned or replaced in response to these study results.

• Brand Name: PRDGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7383839
• MDR Text Key: 103914470
• Report Number: 2032227-2018-02251
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other