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

Lot Number ASKU

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

Patient Problem Reaction, Injection Site (2442)

Event Date 01/01/2020

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.Product is no longer available to be returned.

Event Description

The caller reported a reaction at the injection site of the rapid link infusion set.The caller alleged skin inflammation at the site and after 3 days an abscess had formed.The customer went to the hospital to have the abscess surgically removed.The patient was admitted into the hospital overnight and was discharged the next morning.

• 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: 10148075
• MDR Text Key: 194942482
• Report Number: 3011393376-2020-02061
• 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
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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: 06/09/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR