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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 08/20/2019
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Hospitalization [hospitalisation]. Piston rod was broken at the top of the pen [device breakage]. Case description: this serious spontaneous case from the united states was reported by a consumer as "hospitalization" beginning on (b)(6) 2019, "piston rod was broken at the top of the pen" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy". Medical history was not provided. On an unspecified date, it was reported that the piston rod of novopen echo was broken. On (b)(6) 2019, the patient was hospitalized. Batch number was available. Action taken to novopen echo was reported as unknown. The outcome for the event "hospitalization" was not reported. The outcome for the event "piston rod was broken at the top of the pen" was not reported. Investigation results: name: novopen echo, batch number: hvgm563-2 the product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. Nothing abnormal was found. Manufacturer comment: (b)(6) 2019: as the device (novopen echo) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4). Evaluation summary: name: (b)(6), batch number: hvgm563-2. The product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. Nothing abnormal was found.
 
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Brand NameNOVOPEN ECHO
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA
Manufacturer (Section G)
NOVO NORDISK A/S
krogshoejvej 55
bagsvaerd 2880,
DA
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key9174513
MDR Text Key161800175
Report Number9681821-2019-00068
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2020
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberHVGM563-2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
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