MAUDE Adverse Event Report: U-100 SYRINGE PEN; SYRINGE, PISTON

Device Problems Use of Device Problem (1670); Fail-Safe Problem (2936); Human-Device Interface Problem (2949)

Patient Problem Hypoglycemia (1912)

Event Description

Nurse was up on the floor speaking to her higher up and was wondering if it was okay to draw up insulin from a pen into a syringe as she has done this multiple times as a home health nurse.Higher up said that it was okay but wanted her to call pharmacy to just make sure.Nurse called down to pharmacy to ask if it was okay to draw up insulin from a pen into a syringe.Pharmacist thought this was a weird question and followed up with asking for patient's identification to look further into the question.Pharmacist then realized the insulin the nurse was speaking upon was u-500 insulin.The pharmacist informed the nurse to not draw up the insulin out of the pen and proceeded to find the safety pharmacist to follow up on this issue.The safety pharmacist looked further into the patient and realized that earlier in the day, the patient received u-500 insulin from the same nurse.Keep in mind, our hospital does not stock u-500 insulin syringes.The safety pharmacist proceeded to call the nurse and asked if the nurse drew the insulin out of the pen with a syringe, what syringe they used, and how much insulin they used.U-500 25 units subcutaneously daily was ordered.When speaking with the pharmacist the nurse stated they used the u-100 insulin syringe to draw up the insulin from the u-500 insulin pen and drew up u-500 insulin to the 25 unit mark on the u-100 insulin syringe.Safety pharmacist then proceeded to educate the nurse the difference between u-500 insulin and other insulins along with reasons why drawing up from insulin pens is a safety issue.Nurse and nurse's higher up were unaware of this difference.While speaking with the nurse, the safety pharmacist was told that there were not any pen needles near her and she had just decided to draw up the insulin in a syringe.At the time, the emr did not have any hard stops regarding u-500 insulin but did require a dual sign off before administration for which the higher up nurse gave.Patient did experience hypoglycemia which resulted in treatment.Pt did experience hypoglycemia which resulted in treatment.The following are process changes/strategies that have been/are being implemented.We have updated the u-500 admin instruction: u-500 pen erx: "high alert double check" sign + custom warning "u-500 is a concentrated insulin.Do not transfer from pen into a syringe, severe overdose can result" u-500 solution erx: "high alert double check" sign + custom warning "u-500 is a concentrated insulin.Do not transfer into u100 insulin syringe".Evaluated with all other nursing leadership that it was not a practice in our hospital to draw out insulin from an insulin pen.Nursing will work with storeroom to ensure insulin pen supply is adequate.We will have system education on u-500 to nursing.Inappropriate/inaccurate measuring device knowledge deficit of practitioner; unfamiliar/inexperienced.Error resulted in treatment or intervention; temporary pt harm.(b)(4), submission id: 86525.Ref report: mw5115997.

• Brand Name: U-100 SYRINGE PEN
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 16627137
• MDR Text Key: 312168258
• Report Number: MW5115998
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1