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

Lot Number 5351323

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Hyperglycemia (1905)

Event Date 04/16/2022

Event Type  Injury  

Event Description

The caller reported that on (b)(6) 2022 the self-adhesive of the infusion set was not sticking well enough, and did not adhere to the customer's body.The customer was traveling and did not have any more infusion sets with them.The user experienced an elevated blood glucose result of 290 mg/dl and used back up pen therapy to administer insulin.The customer was traveling and was unable to obtain new infusion sets and had been without pump therapy for 20 hours.On (b)(6) 2022 the customer went to the hospital for high blood glucose levels.The customer was admitted into the hospital for four hours and was treated with lantus insulin to stabilize blood glucose.

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 was discarded and no longer available to be returned.

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 14251471
• MDR Text Key: 290400253
• Report Number: 3011393376-2022-01298
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Lot Number: 5351323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN PEN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male