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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 00048012984
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
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 infusion set was leaking at the headset.
 
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Brand NameACCU-CHEK ® FLEXLINK 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 DEVICES S.A. DE C.V
avenida fomento industrial lot
parque industrial del norte
reynosa C.P. 8873
MX C.P. 88736
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key12688489
MDR Text Key278101536
Report Number3011393376-2021-03290
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeRS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00048012984
Device Lot Number5317267
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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