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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK INSIGHT TENDERLINK INFUSION SET SUBCUTANEOUS INFUSION SET

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ROCHE DIABETES CARE, INC. ACCU-CHEK INSIGHT TENDERLINK INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 00048011814
Device Problems Fluid Leak (1250); Material Twisted/Bent (2981)
Patient Problem Hyperglycemia (1905)
Event Date 04/21/2021
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.
 
Event Description
It was reported that the self-adhesive of the infusion set was wet with insulin due to a bent cannula resulting in elevated blood glucose levels.
 
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Brand NameACCU-CHEK INSIGHT TENDERLINK INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1 - 3
na
osted 4320
DA 4320
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key11805717
MDR Text Key249961999
Report Number3011393376-2021-01474
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/25/2021
Device Catalogue Number00048011814
Device Lot Number1271284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 05/11/2021 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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