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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7230-24
Device Problems Failure To Adhere Or Bond (1031); Separation Failure (2547); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
The patient called in the reported event on a group of cleo 90 devices that are sticking to the inserter or not adhering to the skin. The patient's blood glucose elevated to 380mg/dl and manual injections were performed to resolve. The patient couldn't remember the exact dates(s) that customer experience occurred. Unknown patients condition at this time. Please reference mdr#s: 2183502-2016-01553, 2183502-2016-01554, 2183502-2016-01555, 2183502-2016-01556, 2183502-2016-01557, 2183502-2016-01558, 2183502-2016-01559, 2183502-2016-01560, 2183502-2016-01561, 2183502-2016-01562, 2183502-2016-01563, 2183502-2016-01564, 2183502-2016-01565, 2183502-2016-01566, 2183502-2016-01567, 2183502-2016-01568, 2183502-2016-01569, 2183502-2016-01570. That are also associated with this complaint.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana 55425
MX 55425
Manufacturer Contact
lisa perz
1265 grey fox rd
st. paul, MN 55112
7633833074
MDR Report Key5814463
MDR Text Key50175281
Report Number2183502-2016-01552
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2021
Device Catalogue Number21-7230-24
Device Lot Number76X039
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 Received06/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/21/2016 Patient Sequence Number: 1
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