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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 05/21/2018
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 the patient was hospitalized due to elevated blood glucose levels while wearing the infusion set. It was reported that the patient woke up in the morning with a blood glucose result of 500 mg/dl. The patient experienced elevated blood glucose symptoms of dehydration, feeling sick, and vomited. The patient went to the hospital. At the hospital, the patient was treated for high blood glucose, but the type of treatment given was unknown. The results from the hospital meter were also unknown. The patient stated the high blood glucose was caused because he accidentally slept all night with the transfer set bent, caused by the position of the body in the bed, that obstructed the insulin delivery. The patient was hospitalized for one day. The 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 ® INSIGHT FLEX
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
GERRESHEIMER REGENSBURG GMBH
hirtenstrasse 50
na
pfreimd 92536
GM 92536
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7560872
MDR Text Key109789859
Report Number3011393376-2018-02269
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
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: 06/01/2018 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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