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

Lot Number 5271854

Device Problem Fluid Leak (1250)

Patient Problem Hyperglycemia (1905)

Event Date 06/12/2021

Event Type  malfunction  

Event Description

It was reported that the infusion set was leaking at the headset.

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 has been discarded and can not be returned for evaluation.

• Brand Name: ACCU-CHEK ® SPIRIT TENDERLINK 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): UNOMEDICAL A/S; aaholmvej 1 - 3; na; osted 4320 ; DA 4320
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12920604
• MDR Text Key: 281916391
• Report Number: 3011393376-2021-03735
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 5271854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 12/02/2021 Patient Sequence Number: 1

Treatment

UNKNOWN INSULIN