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

Lot Number 5147747

Device Problem Leak/Splash (1354)

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

Event Date 04/14/2017

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

It was reported that the infusion set was leaking at the headset.Caller also reported that she had an allergic reaction on her abdomen where she inserted the cannula.The caller stated that the site was inflamed, became warm, red, had secretion (pus) with blood, and also a lipodystrophy.The customer went to her doctor who prescribed her amoxicillin for 7 days and an anti-inflammatory for 5 days.The name of the anti-inflammatory was not provided.After treatment there was no longer any inflammation.The customer changed the place where she was inserting the cannula.The infusion set was discarded; therefore, no product could be requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® FLEXLINK 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 DEVICES S.A. DE C.V; avenida fomento industrial lot; parque industrial del norte; reynosa C.P. 8873; MX C.P. 88736
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 6615701
• MDR Text Key: 76796493
• Report Number: 3011393376-2017-03219
• Device Sequence Number: 1
• Product Code: FPA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Lot Number: 5147747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• 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
• Treatment: ANTI-INFLAMMATORY
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR