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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 04631048001
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hyperglycemia (1905)
Event Date 11/22/2022
Event Type  malfunction  
Event Description
It was reported that several infusion sets from the same box were leaking at the headset, resulting in elevated blood glucose levels.
 
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.
 
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Brand Name
ACCU-CHEK ® FLEXLINK 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)
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 Key15855677
MDR Text Key304291766
Report Number3011393376-2022-03469
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodePO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/01/2022
Device Catalogue Number04631048001
Device Lot Number5341657
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received01/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2021
Is the Device Single Use? Yes
Patient Sequence Number1
Patient SexFemale
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