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

Lot Number 32282491

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

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.This case, with patient identifier (b)(6) (system 1), is related to case with patient identifier (b)(6) (system 2).

Event Description

It was reported that the user of the accu-chek rapid-d transfer set had observed that the tubes of 3 new packages of transfer sets easily slip off from the adapter.In one case the user had not noticed that she was without insulin for hours.She reported that she only became aware of it after she had noticed she did not receive insulin and her blood glucose level went up and was checking for the reason.Blood glucose values are unknown.Two lot numbers of transfer sets were provided (lot: 32282491 expiry date 12 jun 2026 and lot: 32055451 expiry date 04 jan 2026) but it can not be determined which lot number was in use at the time of the incident.

• Brand Name: ACCU-CHEK ® RAPID-D 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): CLINICO MEDICAL SP Z O.O.; ul. kocha 1; na; blonie 55-33 0; PL 55-330
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 14344806
• MDR Text Key: 291276892
• Report Number: 3011393376-2022-01398
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 32282491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Age: 46 YR
• Patient Sex: Female