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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Calibration Problem (2890)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 10/03/2020

Event Type  Injury  

Event Description

Event verbatim: hypoglycemic crisis and passed out [hypoglycaemic unconsciousness]; novopen echo is out of calibration, and is applying more insulin than it should [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycemic crisis and passed out(hypoglycemic unconsciousness)" beginning on (b)(6) 2020, "novopen echo is out of calibration, and is applying more insulin than it should(incorrect dose administered by device," with an unspecified onset date, and concerned a (b)(6)- year old male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", fiasp penfill (insulin aspart) solution for injection, 100 u/ml (dose, frequency & route used - not more than 2 iu, unknown) from unknown start date for "type 1 diabetes mellitus".(b)(6).Current condition: type 1 diabetes mellitus (duration not available).Concomitant products included novofine 32g 4mm(needle).It was reported that novopen echo was out of calibration, and was applying more insulin than it should and for that reason the patient had a severe hypoglycemic crisis (18mg/dl) on (b)(6) 2020.The patient was given sachet honey.On (b)(6) 2020, the patient passed out, the mother gave whole milk with sugar.It was reported that the patient had recovered after (b)(6) 2020.The needles are not reused and the pen was not stored with the needle attached.The patient does not use concomitant medications, and has no relevant medical history.Batch numbers: novopen echo: jvgr452-1; fiasp penfill: asku.Action taken to novopen echo was not reported.Action taken to fiasp penfill was not reported.On (b)(6) 2020, the outcome for the event, "hypoglycemic crisis and passed out(hypoglycemic unconsciousness)" was recovered.The outcome for the event "novopen echo is out of calibration, and is applying more insulin than it should (incorrect dose administered by device)" was not reported."in order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The dis-assembled medical device will be stored with the same retention period as other complaint samples.".

Event Description

Case description: investigation results, name: novopen® echo® , batch: jvgr452-1.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.Name: fiasp® penfill® 100 u/ml 3ml, batch: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following has been updated in the case, investigation results updated.Nca reference number updated in eu/ca tab.Annex b,c and d updated.Manufacturer's comment updated.Narrative updated accordingly, references included: reference type: e2b, company number reference id#: (b)(4), reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: (b)(4), reference notes: medwatch 3500a mfr.Report number, reference type: e2b, report duplicate reference id#: (b)(4), reference notes: (b)(6).Final manufacturer comment: on (b)(6) 2020: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation.Batch trend analysis has been performed.No abnormalities relating to the observed problem were found.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Patient is a child with concomitant medical condition of type 1 diabetes mellitus are risk factor for the development of hypoglycaemia.H3 continued: evaluation summary: investigation results, name: novopen® echo®, batch jvgr452-1.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 10778117
• MDR Text Key: 216846984
• Report Number: 9681821-2020-00051
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: JVGR452-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOVOFINE 32G 4MM (NEEDLE) N/A
• Patient Outcome(s): Life Threatening
• Patient Age: 3 YR
• Patient Weight: 15