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

Catalog Number 04545265001

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

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 cannula of the infusion set broke off into the patient's left leg.The patient went to the hospital and is in contact with the doctors regarding the situation.If it unknown if the patient received medical treatment.It is unknown how long the patient was in the hospital.No further information was provided.

Manufacturer Narrative

The infusion set lot number and expiration date were not available at the time of the initial report and have been updated on this report based on the returned product.

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 16786627
• MDR Text Key: 313738816
• Report Number: 3011393376-2023-00929
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04545265001
• Device Lot Number: 32433540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male