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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Partial Blockage (1065)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative
It was unknown if the initial reporter sent a report to the fda.
 
Event Description
Caller reported customer was admitted to the hospital for dka due to a faulty infusion tubing that was partially blocked. He experienced symptoms of vomiting, being sleepy, and moody. His blood glucose measured "hi" on his blood glucose meter (>600 mg/dl). The patient was driven to the hospital by his mother where he was treated with an iv of insulin and another iv of saline solution. Alleged infusion set tubing has been discarded; no product will be returned.
 
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Brand NameACCU-CHEK ® ULTRAFLEX 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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key6757389
MDR Text Key81508790
Report Number3011393376-2017-04316
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101196
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberASKU
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 Received07/18/2017
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: 08/01/2017 Patient Sequence Number: 1
Treatment
HUMALOG U100
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