| Model Number MS9698 |
| Device Problems
Sticking (1597); Failure to Zero (1683); Improper or Incorrect Procedure or Method (2017); Device Operational Issue (2914)
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| Patient Problems
Fatigue (1849); Hypoglycemia (1912)
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Event Type
Injury
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Manufacturer Narrative
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If device is returned, evaluation will be performed to determine if a malfunction has occurred.
This is an initial report.
A follow-up report will be submitted when the final evaluation is completed.
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Event Description
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(b)(4).
This solicited case, reported by a consumer via a patient support program (psp), with additional information from the rcp, concerned a (b)(6) female patient.
Medical history was not reported.
Concomitant medications included vincamine for the treatment of memory and melga (as reported) for an unknown indication.
The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen savvio graphite) 15 iu twice daily, subcutaneously for the treatment of diabetes mellitus beginning on (b)(6) 2016.
On unknown date she changed her human insulin isophane suspension 70%/ human insulin 30% dose to 10 iu three times daily for unknown reason.
Sometime while taking human insulin isophane suspension 70%/ human insulin 30% her humapen savvio graphite was not working, the spring was stuck, and stopped at the mid of the injection and then reporter and patient had to remove it and pressed the spring to return to zero ((b)(4) / lot: unknown).
Reporter was advised by the pharmacist to change the needle with every injection because reporter changed it every 3 to 4 days.
After that humapen savvio graphite was working properly.
It also was reported that when reporter kept the humapen savvio graphite out of the fridge, there was precipitation happened but when he kept the humapen savvio graphite in the fridge, no precipitation happened.
Sometime while taking human insulin isophane suspension 70%/ human insulin 30% she was fatigued and old unable to do exercise.
In addition her sugar levels decreased at night reached 33 mg/dl (no reference range) because she did not eat well.
This event is considered serious due to medical significance.
Her physician changed her dose to 10 iu twice daily with every meal.
After that her sugar levels were good reached 120-130 mg/dl (no reference range).
On (b)(6) 2016 she fell down and broke her arm due to which she was hospitalized for three days and on (b)(6) 2016 she was discharged.
No more details regarding treatment and laboratory tests done while hospitalized were provided.
Information regarding corrective treatment was unknown.
Outcome of the events fell down, broken arm and fatigued was not recovered.
Outcome of the events blood glucose increased and wrong dose was recovered.
Human insulin isophane suspension 70%/ human insulin 30% therapy was continued.
The user of the humapen savvio graphite and her training status was not provided.
The humapen savvio graphite model duration of use and the humapen savvio graphite duration of use were not reported.
The action taken with the humapen savvio graphite was continued and its return was not expected.
The reporting consumer did not provide an assessment of relatedness between the events and human insulin isophane suspension 70%/ human insulin 30% or humapen savvio graphite.
Update 03-nov-2016: initial information received on 29-oct-2016 and follow up information received on 01-nov-2016 were processed at the same time.
Update 04nov2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.
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Manufacturer Narrative
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Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem.
Please refer to statement dated 30nov2016 in describe event or problem.
No further follow up is planned evaluation summary a female patient reported her humapen savvio device "was not working.
" the spring was stuck and stopped at the middle of the injection.
The patient experienced decreased blood glucose.
The device was not returned to the manufacturer for investigation (batch unknown).
Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.
Malfunction unknown.
However, the complaint narrative indicates a pharmacist was consulted, and the pharmacist advised the patient to change the needle with every injection.
The patient indicated the needle was changed every three (3) to four (4) days.
The device was working properly after consultation with the pharmacist.
All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.
The user manual instructs to use a new needle for each injection and to not store the pen in a refrigerator.
There is evidence of improper use and storage.
The patient reused needles and stored the humapen savvio device in the refrigerator.
It is unknown if these are relevant to the event of decreased blood glucose.
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Event Description
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(b)(4).
This solicited case, reported by a consumer via a patient support program (psp), with additional information from the rcp, concerned a (b)(6) female patient.
Medical history was not reported.
Concomitant medications included vincamine for the treatment of memory and melga (as reported) for an unknown indication.
The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) via reusable pen (humapen savvio graphite) 15 iu twice daily, subcutaneously for the treatment of diabetes mellitus beginning on (b)(6) 2016.
On unknown date she changed her human insulin isophane suspension 70%/ human insulin 30% dose to 10 iu three times daily for unknown reason.
Sometime while taking human insulin isophane suspension 70%/ human insulin 30% her humapen savvio graphite was not working, the spring was stuck, and stopped at the mid of the injection and then reporter and patient had to remove it and pressed the spring to return to zero ((b)(4) / lot: unknown).
Reporter was advised by the pharmacist to change the needle with every injection because reporter changed it every 3 to 4 days.
After that humapen savvio graphite was working properly.
It also was reported that when reporter kept the humapen savvio graphite out of the fridge, there was precipitation happened but when he kept the humapen savvio graphite in the fridge, no precipitation happened.
Sometime while taking human insulin isophane suspension 70%/ human insulin 30% she was fatigued and old unable to do exercise.
In addition her sugar levels decreased at night reached 33 mg/dl (no reference range) because she did not eat well.
This event is considered serious due to medical significance.
Her physician changed her dose to 10 iu twice daily with every meal.
After that her sugar levels were good reached 120-130 mg/dl (no reference range).
On (b)(6) 2016 she fell down and broke her arm due to which she was hospitalized for three days and on (b)(6) 2016 she was discharged.
No more details regarding treatment and laboratory tests done while hospitalized were provided.
Information regarding corrective treatment was unknown.
Outcome of the events fell down, broken arm and fatigued was not recovered.
Outcome of the events blood glucose increased and wrong dose was recovered.
Human insulin isophane suspension 70%/ human insulin 30% therapy was continued.
The user of the humapen savvio graphite and her training status was not provided.
The humapen savvio graphite model duration of use and the humapen savvio graphite duration of use were not reported.
The action taken with the humapen savvio graphite was continued and its return was not expected.
There is evidence of improper use and storage.
The patient reused needles and stored the humapen savvio device in the refrigerator.
The reporting consumer did not provide an assessment of relatedness between the events and human insulin isophane suspension 70%/ human insulin 30% or humapen savvio graphite.
Update 03-nov-2016: initial information received on 29-oct-2016 and follow up information received on 01-nov-2016 were processed at the same time.
Update 04nov2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.
Update 30nov2016.
Follow up received 30nov016 from the product complaint safety database.
On the device tab entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly.
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Search Alerts/Recalls
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