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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 5149488
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 02/08/2012
Event Type  Injury  
Event Description
Caller reported experiencing a chronic rash requiring treatment from her dermatologist; was given a prescription for ointment. Caller alleges infusion set causes the rash. Alleged cannulas have 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 Key6363861
MDR Text Key68499811
Report Number3011393376-2017-01186
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
Type of Report Initial,Followup
Report Date 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2018
Device Lot Number5149488
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 Received03/01/2017
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: 02/28/2017 Patient Sequence Number: 1
Treatment
FLUOCINONIDE 5%; HUMALOG U100; METFORMIN
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