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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number 32396245
Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2018
Event Type  malfunction  
Event Description
It was reported that the self-adhesive of the infusion set was not sticking well enough and that the self-adhesive was wet with insulin. No adverse event was reported. The infusion set is not expected to be returned for product evaluation.
 
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Brand NameACCU-CHEK ® RAPID-D INFUSION SET
Type of DeviceSUBCUTANEOUS 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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7502465
MDR Text Key107849965
Report Number3011393376-2018-02007
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003977
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number32396245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/10/2018 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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