MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE; SPRING LOADED INSERTION DEVICE

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 02/01/2019

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 alleged that the insertion device was not fully inserting the cannula properly.It was alleged that the linkassist plus device would not fully insert the cannula into the skin; the patient would have to manually push the cannula in the rest of the way.The caller alleged this led to hyperglycemia.The patient reported that she had elevated blood glucose symptoms and went to the hospital.Upon arrival at the hospital the patient received a blood glucose result of 32 mmol/l and ketones of 7.The patient was diagnosed with diabetic ketoacidosis and was treated with a saline and insulin drip.At the time of the report the patient was still hospitalized, it is unknown when they will be discharged.The lot number was not provided.The insertion device is not expected to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE
• Type of Device: SPRING LOADED INSERTION DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; na; bad oeynhausen 32549 ; GM 32549
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 8342925
• MDR Text Key: 136247610
• Report Number: 3011393376-2019-00644
• Device Sequence Number: 1
• Product Code: KZH
• 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
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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
• Date Manufacturer Received: 02/02/2019
• 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
• Treatment: NOVORAPID INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR