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

Lot Number ASKU

Device Problem Device Issue (2379)

Patient Problem Hematoma (1884)

Event Date 11/01/2014

Event Type  Injury  

Manufacturer Narrative

The event occurred in (b)(6).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

Caller reported customer had a surgery on his buttocks for a coagulated blood mass under the skin due to a cannula.Caller stated she noticed a red mark on the left side buttock and there may have been a lump; went to the doctor who provided a cream which had no effect.Caller reported the red mark progressively got redder, bigger, and had crusty scabs; referred to endocrinologist and hospital where he was admitted for surgery.Cannula has been discarded.No product will be returned.

• Brand Name: ACCU-CHEK ® RAPID-D 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): CLINICO MEDICAL SP Z O.O.; ul. kocha 1; na; blonie 55-33 0; PL 55-330
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 5651197
• MDR Text Key: 45057410
• Report Number: 3011393376-2016-03160
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• 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: 4 YR