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

Lot Number ASKU

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

Patient Problems Abscess (1690); Hyperglycemia (1905)

Event Date 11/09/2018

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

It was reported that the patient was hospitalized for an abdominal abscess while using the infusion set.The patient's blood glucose result was 500 mg/dl and she had hyperglycemia symptoms of feeling sick, nausea, and vomiting.The patient's abdomen puncture area had signs of inflammation with skin swelling, redness, and elevated skin temperature.Her husband contacted the paramedics and she was transported to the hospital.In the hospital, the abdominal abscess was operative opened.The patient was treated with antibiotics via infusion and antibiotic tablets after being released from the hospital.The patient was hospitalized from (b)(6) 2018.The infusion set lot number was not provided.The infusion set was discarded; therefore, no product could be requested to be returned for product evaluation.

• 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: 8120624
• MDR Text Key: 128917872
• Report Number: 3011393376-2018-04867
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• 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
• Date Manufacturer Received: 11/13/2018
• 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: 39 YR