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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
Lot Number 5316630
Device Problem Fluid/Blood Leak (1250)
Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364); Syncope/Fainting (4411)
Event Date 10/27/2021
Event Type  Injury  
Event Description
It was reported that the infusion set was leaking at the headset. On (b)(6) 2021, the patient was hospitalized with hyperglycemia and ketoacidosis. The blood glucose result was hi mg/dl. She had symptoms such as vomiting, fainting, nausea, loss of appetite and rapid heartbeat. The patient was removed from the pump and treated with humalog insulin. On (b)(6) 2021, the pump was reconnected and the hospital checked that the pump was working normally. The patient was hospitalized until (b)(6) 2021, when she went back home with a blood glucose level of 112 mg/dl and on arrival at home she obtained a low blood glucose result of 68 mg/dl.
 
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. The customer discarded the products.
 
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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 Key12781088
MDR Text Key280539753
Report Number3011393376-2021-03483
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
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 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2022
Device Lot Number5316630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/12/2021
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: 11/09/2021 Patient Sequence Number: 1
Treatment
HUMALOG INSULIN
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