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

Lot Number ASKU

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

Patient Problems Hematoma (1884); Injection Site Reaction (4562)

Event Date 02/01/2020

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.Product is no longer available to be returned for evaluation.

Event Description

The caller reported that he was hospitalized twice due to an abscess/hematoma formation from wearing the infusion set.The caller reported the first hospitalization was in (b)(6) of 2020.He stated he received 5 surgical operations to remove the abscess and spent 2 weeks in inpatient care.The date of the 2nd hospitalization is unknown.The customer also reported receiving a surgical operation to remove an abscess and was hospitalized for 2 days for this event.

• 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: 11084105
• MDR Text Key: 224027130
• Report Number: 3011393376-2020-04653
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/28/2020

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
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Device Age: NULL
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR