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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM SILHOUETTE PARADIGM INFUSION SET

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UNOMEDICAL A/S SILHOUETTE PARADIGM SILHOUETTE PARADIGM INFUSION SET Back to Search Results
Model Number MMT-377
Device Problem Detachment Of Device Component (1104)
Patient Problem Coma (2417)
Event Type  Injury  
Manufacturer Narrative
Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 03-oct-2016.
 
Event Description
(b)(4). The complaints stated that infusion set was pulled during sleep, resulting in the patient's blood glucose running high (above 500 mg/dl) where the patient went into a diabetic coma and was hospitalized. Patient couldn't remember the exact date of the hospitalization but stated it was around (b)(6) of 2015. No information on the infusion set used at the time of hospitalization was provided. The patient reported that the customer was having kidney failure. The patient reported that he was not wearing the insulin at the time of hospitalization. The patient was off the pump 12 hours the most. The patient reported that he ripped out the infusion set in the middle of the night and blood glucose went high. No further information available.
 
Manufacturer Narrative
On 03-oct-2016: no relevant testing could be performed. Since the lot number was not available, the batch records and the complaint database could not be reviewed for relevant deviations. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 03-nov-2016. On 02-sep-2016: unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 03-oct-2016.
 
Event Description
(b)(4). The complaints stated that infusion set was pulled during sleep, resulting in the patient's blood glucose running high (above 600 mg/dl) where the patient went into a diabetic coma and was hospitalized. Patient couldn't remember the exact date of the hospitalization but stated it was around (b)(6) 2015. No information on the infusion set used at the time of hospitalization was provided. The patient reported that the customer was having kidney failure. The patient reported that he was not wearing the insulin at the time of hospitalization. The patient was off the pump 12 hours the most. The patient reported that he ripped out the infusion set in the middle of the night and blood glucose went high. No further information available.
 
Manufacturer Narrative
On 02-nov-2016: the claimed failure cannot be confirmed. No relevant testing could be performed. Since the lot number was not available, the batch records and the complaint database could not be reviewed for relevant deviations. No further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents. Clinical evaluation:the patient contacted the call center due to fluctuations in blood glucose levels. During troubleshoot it was found that patient was not able to insert infusion set as per instruction for use because of neck injury. The patient mentioned an earlier event where the infusion set was accidentally pulled out during sleep. Due to interrupted flow of insulin to the subcutaneous tissue and therefore elevated blood glucose level the patient went into diabetic coma. Also, the patient reported having kidney failure but no information whether this is due to longtime diabetes or a consequence of the hyperglycemic event is available. The patient did not report length of hospital stay or type of medical intervention. On 03-oct-2016: no relevant testing could be performed. Since the lot number was not available, the batch records and the complaint database could not be reviewed for relevant deviations. Unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 03-nov-2016. On 02-sep-2016: unomedical is actively seeking further information on the incident. Unomedical is expected to submit a follow up (or final) emdr report not later than 03-oct-2016.
 
Event Description
(b)(4). The complaints stated that infusion set was pulled during sleep, resulting in the patient's blood glucose running high (above 600 mg/dl) where the patient went into a diabetic coma and was hospitalized. Patient couldn't remember the exact date of the hospitalization but stated it was around (b)(6) 2015. No information on the infusion set used at the time of hospitalization was provided. The patient reported that the customer was having kidney failure. The patient reported that he was not wearing the insulin at the time of hospitalization. The patient was off the pump 12 hours the most. The patient reported that he ripped out the infusion set in the middle of the night and blood glucose went high. No further information available.
 
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Brand NameSILHOUETTE PARADIGM
Type of DeviceSILHOUETTE PARADIGM INFUSION SET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
548167000
MDR Report Key5952299
MDR Text Key54774898
Report Number8021545-2016-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-377
Device Lot NumberUNKNOWN
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 Received08/11/2016
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/15/2016 Patient Sequence Number: 1
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