MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED QUICK-SET; SET, ADMINISTRATION, INTRAVASCULAR LUNAR

Lot Number 5248459

Device Problems Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Difficult to Remove (1528); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Event Description

The problem has occurred from circa (b)(6) 2019 until the present.Several components of my medtronic 670g insulin pump system have malfunctioned.The most serious problem is with minimed quick-set infusion sets.For reference number: mmt-397, lot number 5248459 and lot number 5248467, the quick-set release does not securely click and lock onto the cannula assembly so as to ensure a continuous and unimpeded flow of insulin as administered by the 670g pump.The quick-set, based on my first experience with the 670g system, noticeably snaps into the locked position on the cannula assembly so that it cannot be unlocked and removed without applying firm pressure on the quick-set release with one's thumb and opposing finger.That is what aligns the tubing and port on the cannula assembly to provide a secure path for infusion of insulin into the patient.However, with at least four infusion sets from the lots, supra, though the quick-set snapped into place, the snap wasn¿t robust, and i easily removed the quick-set from the cannula's assembly with a simple and easy twisting motion, without the need of applying any pressure to the sides of the quick-set to unlock and release it.With infusion sets from the lots, supra, none of them have so far required any pressure to release them from the cannulas assembly.One quick-set simply fell off; one has leaked; another simply didn¿t infuse any insulin, which caused the 670g pump to issue a blocked flow warning.The last, i am now wearing, simply because i don't have much inventory at home that hasn¿t been affected by this problem.The 670g's cgm sensors have also been a problem.With two of those sensors, the tape adhering them to me simply came lose, which ruined the sensors, i now have to use iv tape to secure the cgm sensors to my body.The other problem with sensors, depending on the sensor, their standard deviation from the glucometer readings was either too greatly underestimating or overestimating the glucometer readings.I have made detailed reports to medtronic on these problems and have just this morning alerted my endocrinologist, doctor (b)(6) of (b)(6) clinic of these problems.Sincerely, (b)(6).

• Brand Name: MINIMED QUICK-SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR LUNAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8261131
• MDR Text Key: 133833816
• Report Number: MW5083239
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 5248459
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 138