MAUDE Adverse Event Report: ROCHE DIABETES CARE GMBH FASTICLIX; LANCET,BLOOD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Pain (1994); Swelling (2091)

Event Date 08/04/2020

Event Type  Injury  

Event Description

I purchased an accu-chek guide blood glucose meter kit from (b)(6) on (b)(6) 2020.On (b)(6)2020 i tested my blood sugar at 1:16 pm using the fastclix lancing device and drum included.The lancing device is a new design which attaches to a drum with 6 lancets inside it.I set it on level 1 which is for thin skin.Using my left hand, side of index finger to test, it caused a lot of pain.I ran water on my finger after which made it burn.I may have seen what looked like two cuts - blood areas, but i did not focus on it.At 4:05 pm i used the left hand side of second finger to check the blood sugar.I set the device on either 1 or.5.Again, i experienced sharp pain and saw 3 areas of my skin cut and a raised area.My friend was present during both checks and took a photo of my second finger and the lancet drum which i could email if needed.I do not know how to upload photos as i see is an option.I called the company and told them what happened.They did not want to refund me the full amount of which i purchased the kit, test strips and additional lancets.I told them i thought they should look at the device so they are sending an envelope to me.I was told a supervisor type person would receive my complaint.That evening i called an on call physician who told me to use neosporin and (b)(6) and i needed to be seen in case stitches were needed.I agreed to the next day (b)(6) appointment.I was seen at the (b)(6) by a physician assistant on (b)(6) 2020.He looked at the photo and the lancet device.He commented on the bruising on my fingers.He said it should be reported, and i told him i had called the company and an envelope was being sent to me to mail the meter kit back to them.The accu-chek guide box, s/n is (b)(4), lot: 205975, exp: 2023-02-04 roche.The fastclix drum has a code printed on it - (b)(4).Around (b)(6) i was given a case number from the first person i had spoken with # (b)(4).I sent the company the photo of my finger by email.I have not received the return mailing envelope yet from the company and saw below you may want to examine it.Please let me know if you need it.Fda safety report id# (b)(4).

• Brand Name: FASTICLIX
• Type of Device: LANCET,BLOOD
• Manufacturer (Section D): ROCHE DIABETES CARE GMBH
• MDR Report Key: 10396021
• MDR Text Key: 202728289
• Report Number: MW5096013
• Device Sequence Number: 2
• Product Code: FMK
• 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: 08/07/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 62