MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® SPIRIT COMBO; INSULIN INFUSION PUMP

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

Patient Problem Caustic/Chemical Burns (2549)

Event Date 12/24/2018

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 that on (b)(6) 2018 the patient experienced a chemical burn from the lithium battery inside her infusion device.The reporter stated that the patient had her infusion device inside a sock which was positioned inside her bra.The patient began to feel a painful sensation in the area where the device was being stored.The patient discovered a burn which was roughly 0.5 inches - 2 inches in diameter on her skin.The patient noticed when changing the battery that there was a 'white substance' on the inside of the battery chamber and on the battery.Patient reported after noticing that the burn was beginning to turn yellow in color she started to take a course of antibiotics that she happened to have with her on vacation "just in case".The patient began to experience elevated blood glucose levels and attributes this to the antibiotics.It was reported that the burn was getting progressively worse.On (b)(6) 2019 the patient went to the hospital.The hospital cleaned the burn and applied a mesh dressing.The patient was advised to return to hospital in 2 days for follow up.The patient returned to the hospital on (b)(6) 2019 and it was discovered that the burn had gotten progressively worse and was now black and yellow.The hospital referred the patient to a burn unit of a different hospital.On (b)(6) 2019 the patient attended the burn unit of the 2nd hospital and the doctor's confirmed the burn was caused by a chemical.Patient advised that chemical burns typically will gradually get worse over time, which correlates to the patient's symptoms.The doctor's at the burn unit dressed the wound and advised the patient of aftercare procedure.The patient has a follow up appointment on (b)(6) 2019.At her follow up appointment on (b)(6) 2019 the doctor's will remove the top layer of black skin, after the burn has been given some time to heal naturally.The infusion device was requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® SPIRIT COMBO
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 8275297
• MDR Text Key: 134016842
• Report Number: 3011393376-2019-00328
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR