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

Model Number	04541642001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Unspecified Infection (1930); Reaction, Injection Site (2442)
Date of Event	01/25/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9699586
• Report Number: 3011393376-2020-00588
• Device Sequence Number: 1964492
• Product Code: FPA
• UDI-Device Identifier: 05705244008656
• UDI-Public: 05705244008656
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 05/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention