MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® TENDER INFUSION SET; SUBCUTANEOUS INFUSION SET

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Reaction, Injection Site (2442)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

Product is no longer available to be returned for evaluation.

Event Description

It was reported that the patient experienced an abscess on the stomach at the infusion site.The patient experienced skin inflammation including a rash, itching, and a blister.The patient went to the dermatologist.The dermatologist performed a small surgical procedure to remove the abscess, which was the size of a large grape.The caller reported this was an outpatient procedure.The patient was prescribed an unknown medication to use for few days following the procedure.The caller could not recall the name of the medication.Another incident occurred 4-6 months ago where the patient experienced an abscess on the stomach at the infusion site.The patient experienced skin inflammation including a rash, itching, and a blister.Caller reported that it was a smaller abscess in this instance.She went to the dermatologist.The dermatologist gave her 2 prescription antibiotics and one prescription cream.The caller does not recall the names of these medications.Medications were taken for a few days and the abscess was resolved.No surgical procedure occurred.

• Brand Name: ACCU-CHEK ® TENDER INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1 - 3; na; osted 4320 ; DA 4320
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 9621280
• MDR Text Key: 177043257
• Report Number: 3011393376-2020-00266
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Device Age: NULL
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 107