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

Catalog Number 04545192001

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

Patient Problem Reaction, Injection Site (2442)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

The caller reported that the patient had an allergic reaction to the infusion set.It was reported that the patient had an abscess in various locations on the abdominal area.On (b)(6) 2018 the patient inserted a new radid-d link cannula; by friday, (b)(6) 2018, the area was red and presented pain.The patient went to the doctor.The doctor presumed that it was deep-seated encapsulated pus, caused by a delayed reaction to the steel rapid-d link cannula.It was determined that the patient would need surgery.The first surgery took place on (b)(6) 2018 with a superficial incision to remove pus.However, through this process no pus was extracted.On (b)(6) 2018 the patient underwent a 2nd surgery under general anesthesia.The pus was removed by placing a tube inside the wound.It was reported that there would be a 3rd surgery to take place on (b)(6) 2018.The patient would be under general anesthesia for removal of two further small abscesses (one newly formed on (b)(6) 2018, another older one).Both abscesses also occurred in places where the infusion set had previously been placed.At the time of the report the patient was still hospitalized, it is unknown when they will be discharged.The infusion set was requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® RAPIDLINK 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): FRESENIUS KABI DEUTSCHLAND GMBH; robert-koch-strasse 5; na; bad hersfeld D-362 51; GM D-36251
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 8059780
• MDR Text Key: 126906039
• Report Number: 3011393376-2018-04689
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2022
• Device Catalogue Number: 04545192001
• Device Lot Number: 32463417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR