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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Hyperglycemia (1905)
Event Date 11/09/2018
Event Type  Injury  
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 patient was hospitalized for an abdominal abscess while using the infusion set. The patient's blood glucose result was 500 mg/dl and she had hyperglycemia symptoms of feeling sick, nausea, and vomiting. The patient's abdomen puncture area had signs of inflammation with skin swelling, redness, and elevated skin temperature. Her husband contacted the paramedics and she was transported to the hospital. In the hospital, the abdominal abscess was operative opened. The patient was treated with antibiotics via infusion and antibiotic tablets after being released from the hospital. The patient was hospitalized from (b)(6) 2018. The infusion set lot number was not provided. The infusion set was discarded; therefore, no product could be requested to be returned for product evaluation.
 
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Brand NameACCU-CHEK ® RAPID-D INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
CLINICO MEDICAL SP Z O.O.
ul. kocha 1
na
blonie 55-33 0
PL 55-330
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key8120624
MDR Text Key128917872
Report Number3011393376-2018-04867
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
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: 11/30/2018 Patient Sequence Number: 1
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