MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® RAPIDLINK INFUSION SET; SUBCUTANEOUS INFUSION SET

Catalog Number ASKU

Device Problem Defective Device (2588)

Patient Problem Infiltration into Tissue (1931)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Hospital patient alleges the nurse found the needle had broken and remained in the patient's abdominal subcutaneous tissue when she changed the cartridge and infusion set.Patient stated the needle had been used 6 days.Patient reported the nurse said there was no excessive force used.Patient stated the issue occurred while he is in the hospital and the doctor removed the needle through an operation; remains under treatment in the hospital.Patient reported his blood glucose level is steady; no actual results were provided.Requested return of the alleged infusion set for evaluation.

Manufacturer Narrative

The event occurred in (b)(6).

• Brand Name: ACCU-CHEK ® RAPIDLINK INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): FRESENIUS KABI DEUTSCHLAND GMBH; robert-koch-strasse 5; na; bad hersfeld D-36 251; GM D-36251
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3688033
• MDR Text Key: 4297108
• Report Number: 1823260-2014-01904
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: ASKU
• Device Lot Number: 32352262
• Other Device ID Number: 00700006940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 050 YR