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

Model Number 04541642001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Reaction, Injection Site (2442)

Event Date 01/25/2020

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

The caller reported allergic reactions and infections while wearing the tenderlink cannula's.The caller reported an allergy since (b)(6) 2019, but recently got an infection.The patient reported having 3 medical procedures to drain the pus from the site.The caller reported symptoms of itching and redness at the site.Caller alleged that due to infections blood glucose levels have increased.The patient was prescribed antibiotics to treat the infection.The type of antibiotic prescribed was unknown.It is unknown how long the patient was hospitalized or if these were outpatient procedures.

• 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: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 9699586
• MDR Text Key: 178759432
• Report Number: 3011393376-2020-00588
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244008656
• UDI-Public: 05705244008656
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2023
• Device Model Number: 04541642001
• Device Catalogue Number: 04541642001
• Device Lot Number: 5255613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention