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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI-AVENTIS DEUTSCHLAND GMBH MY DOSE COACH INSULIN DELIVERY

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SANOFI-AVENTIS DEUTSCHLAND GMBH MY DOSE COACH INSULIN DELIVERY Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Based on the information provided by reporter dated 14-aug-2019, the causal role of suspect drug, insulin glargine seems doubtful with respect to serious event, my dose coach due to lack of any etiological role and / or direct pharmacological impact of the same. However due to absence of any other stronger confounding factors, the causal role of device cannot be completely ruled out. Lack of detailed information precludes a comprehensive assessment.
 
Event Description
Device malfunction without adverse event [device malfunction]. Case narrative: initial information received on 19-jul-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program (b)(4). Center id: unknown; patient id: unknown; country: (b)(6). Study title: (b)(6). This case involves an unknown age female patient for whom device malfunction was reported while he/she was treated with insulin glargine(toujeo) and with the use of medical devices my dose coach. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient started taking insulin glargine dosing details unknown (with an unknown batch number) for an unknown indication. On an unknown date,(latency unknown) it was reported that the reporter tried to register a patient on the testing environment (qa) instead of register him on the productive environment. Instead of the production environment a (b)(6) educator has used medtech's development environment to register a patient. He got access because he used the qa platform in order to practice for workshops; nevertheless, the patient begun the titration adjustment. Additionally, it was mentioned that the health care provider does not want to delete the patient register because the adjustment is ongoing, so our colleagues wait for your instructions. The development environment is mostly used for training purpose and thus, access is granted to different people within sanofi. This issue does not impact or affect the overall intended functionality of the application but it does pose a safety risk to patients. This issue has the potential to cause harm to the patient due to the fact that any user in the qa environment has the ability make changes to the real patient's plan. Also, users in the environment may be able to access features that have not been fully tested or implemented. This occurred due to the incorrect use of the product by an affiliate. There was no error on the product and the product functioned as normal. Additionally, there is no adverse event reported due to this issue. Risk mitigations are being added to the product to minimize future occurrences in the upcoming 1. 2. 1 release. Medtech has raised a deviation to add a clear indication to the user interface of the development environment; a permanent banner will be added to avoid mixing up the portals in the future. Furthermore the patient`s dose plan has been discontinued on the development environment, and a new one registered on the production environment. Overall company conclusion is that this case is related to misuse. Action taken: not applicable. It was not reported if the patient received a corrective treatment. Event outcome: not applicable. Reporter causality: not reported for drug and device my dose coach. Company causality: not reportable for drug and reportable for device my dose coach. A product technical complaint (ptc) was initiated on 13-aug-2019. For insulin glargine (toujeo). Batch number: unknown, global ptc number: (b)(4). Company language: 13-aug-2019, 2019-08-13 (b)(4) medtech (us cam investigation report):(b)(4) title: clinical educator registered patient in qa environment. Frequency of occurrence seen once investigation this occurred due to the incorrect use of the product by an affiliate. There was no error on the product and the product functioned as normal. Risk mitigations are being added to the product to minimize future occurrences in the upcoming 1. 2. 1 release. For more details, please review the root cause use errors (works as designed, unsupported feature)conclusion instead of the production environment a (b)(6) educator has used medtech's development environment to register a patient. The development environment is mostly used for training purpose and thus, access is granted to different people within sanofi. There was no error on the product and the product functions as intended. However medtech has raised a deviation to add a clear indication to the user interface of the development environment, a permanent banner will be added to avoid mixing up the portals in the future. Furthermore the patient`s dose plan has been discontinued on the development environment, and a new one registered on the production environment. Sample status: not applicable. Summarized conclusion: related to misuse / forced damage. Final investigation complete date: 13-aug-2019. Information on the batch number was requested. No further relevant information was received.
 
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Brand NameMY DOSE COACH
Type of DeviceINSULIN DELIVERY
Manufacturer (Section D)
SANOFI-AVENTIS DEUTSCHLAND GMBH
d-65926 industriepark hochst -
building h500
frankfurt am main 65926
GM 65926
Manufacturer (Section G)
SANOFI-AVENTIS DEUTSCHLAND GMBH
d-65926 industriepark hochst -
building h500
frankfurt am main 65926
GM 65926
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8919444
MDR Text Key159840912
Report Number3010770778-2019-00002
Device Sequence Number1
Product Code NDC
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 08/22/2019 Patient Sequence Number: 1
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