MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® SPIRIT ADAPTER; SPRING LOADED INSERTION DEVICE

Lot Number ASKU

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

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

It was reported that the adapter would not tighten and thus allowed insulin to leak into the cartridge compartment of the infusion device.No adverse event was reported.The adapter was requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® SPIRIT ADAPTER
• Type of Device: SPRING LOADED INSERTION DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): TEUSCHER KUNSTSTOFF-TECHNIK AG; niklaus-wengi-strasse 38; sandhoferstrasse 116; grenchen 2540 ; GM 2540
• Manufacturer Contact: greg smith ; 9115 hague road; 9115 hague road; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 5431269
• MDR Text Key: 38045798
• Report Number: 3011393376-2016-01245
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 66