MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET; PEN NEEDLE

Model Number	32G X 4MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient said in today because he must use 4 to 5 pn to complete 1 injection.He has been using droplet for 3 months, and used other brand previously.He stated that during the injection, the pen will just stop dispensing the insulin resulting in the patient having to not only switch pn several times but, stick himself more than once.He stated this happens often, but could not provide a certain amount.The patients' blood sugar registers high since using this product, which is unusual for him, as this never happened with other brand.Patient does not reuse pn, and they are not bent in any way when they are removed.

• Brand Name: DROPLET
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 10558600
• Report Number: 9613304-2020-00028
• Device Sequence Number: 11410815
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)240701(10)Z58M2
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K171982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2024
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: Z58M2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1