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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK RAPIDLINK INFUSION SET; SUBCUTANEOUS INFUSION SET
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ROCHE DIABETES CARE, INC. ACCU-CHEK RAPIDLINK INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number 32041420
Device Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Injection Site Reaction (4562)
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 customer suffered several infections at the insertion site of the infusion set.The caller reported the first incident happened a few months ago.The customer got an infection due to the cannula and was hospitalized.The customer reported she went to hospital and they had to cut the would.The customer was hospitalized for 5 days and treated with unknown antibiotics.The customer reported the same thing occurred 1.5 weeks ago and again at the time of the report.For the last two occurrences, the customer went to the doctor and they had to "cut the wound." the caller reported that due to the infection, insulin does not enter the body and she experienced elevated blood glucose results.At the time of the report the patient was home and stable.
 
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Brand Name
ACCU-CHEK RAPIDLINK INFUSION SET
Type of Device
SUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
MDR Report Key11260074
MDR Text Key229674244
Report Number3011393376-2021-00349
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number32041420
Was Device Available for Evaluation? No
Date Manufacturer Received04/28/2021
Patient Sequence Number1
Treatment
UNKNOWN INSULIN; UNKNOWN INSULIN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age49 YR
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