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

Catalog Number 05511097001

Device Problem Difficult to Insert (1316)

Patient Problem Hyperglycemia (1905)

Event Date 08/15/2022

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 insertion device didn't insert the cannulas correctly, as the customer's blood glucose levels elevate when she uses this insertion device.On (b)(6) 2022, a few hours after using the insertion device, the customer's blood glucose level was reading hi (= higher than the measurement range of the meter) on her meter.She also had ketone bodies (amount unknown).The patient went to hospital where she was treated with a drip.She stayed in the hospital for 7.5 hours before her blood glucose levels returned to normal and she was allowed to go home.The customer also noticed that after using the device the cannula looked bent.

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 15869511
• MDR Text Key: 304356768
• Report Number: 3011393376-2022-03491
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 05511097001
• Device Lot Number: 1702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female