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

Lot Number ASKU

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2021

Event Type  malfunction  

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 no longer available for return.

Event Description

It was reported that the infusion set was leaking at the headset and the self-adhesive of the infusion set was wet with insulin.

• 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: 11420943
• MDR Text Key: 234968257
• Report Number: 3011393376-2021-00738
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Age: 10 YR