MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC; MOZ

Lot Number 7RSA001ZB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Glycaemia changed a lot (rose above 500 mg / dl) [hyperglycemia] case narrative: this unsolicited case from (b)(6) was received on (b)(6) 2018 (additional information was received on (b)(6) 2018, both the information was processed together with clock start date of (b)(6) 2018) from a patient.This case concerns a male patient (age not provided) who received treatment with synvisc injection and after unknown latency had glycaemia changed a lot (rose above 500 mg / dl).No medical history, past drug, concomitant medication and concurrent condition was provided.On an unknown date, patient received treatment with intra- articular synvisc injection (dose, indication and expiration date: not provided; lot number: 7rsa001zb).On an unknown date, after unknown latency, patient's glycaemia changed a lot (rose above 500 mg / dl) since first synvisc application.Patient's doctor prescribed him 3 synvisc applications; he had already performed 2 of them.Before performing the third application, patient wanted to know if the change in glycaemia was related to the use of the product.Patient's doctor informed that the change in glycaemia was related to his emotional state.Also reported that the product was prescribed to him because he could not undergo surgery and neither arthroscopy.Due to the condition of hyperglycemia, patient was hospitalized and received the insulin to establish his glycemic levels.It was not reported if the physician was informed about the case.Action taken: unknown corrective treatment: insulin outcome: recovered a pharmaceutical technical complaint (ptc) was initiated on 15-may-2018 for synvisc with global ptc number: (b)(4).The production and quality control documentation for lot 7rsa001zb expiration date (2019-12-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 7rsa001zb no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 14-jun-2018 there was only 1 complaint on file for lot 7rsa001zb and all related sublots.1 complaint was on file for lot 7rsa001zb: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.Seriousness criteria: hospitalization follow up information received on 15-may-2018.No new information received.Additional information was received on (b)(6) 2018.Ptc results were added.Lot number was updated from 7rsa0012b to 7rsa001zb and expiry date was added.Text was amended accordingly upon internal review on (b)(6) 2018, the company causality was updated from reportable to not reportable.

Event Description

Glycaemia changed a lot (rose above 500 mg / dl) [hyperglycemia].Case narrative: this unsolicited case from brazil was received on 07-may-2018 (additional information was received on 08-may-2018, both the information was processed together with clock start date of on (b)(6) 2018) from a patient.This case concerns a male patient (age not provided) who received treatment with synvisc injection and after unknown latency had glycaemia changed a lot (rose above 500 mg / dl).No medical history, past drug, concomitant medication and concurrent condition was provided.On an unknown date, patient received treatment with intra- articular synvisc injection (dose, indication and expiration date: not provided; lot number: 7rsa001zb).On an unknown date, after unknown latency, patient's glycaemia changed a lot (rose above 500 mg / dl) since first synvisc application.Patient's doctor prescribed him 3 synvisc applications; he had already performed 2 of them.Before performing the third application, patient wanted to know if the change in glycaemia was related to the use of the product.Patient's doctor informed that the change in glycaemia was related to his emotional state.Also reported that the product was prescribed to him because he could not undergo surgery and neither arthroscopy.Due to the condition of hyperglycemia, patient was hospitalized and received the insulin to establish his glycemic levels.It was not reported if the physician was informed about the case.Action taken: unknown.Corrective treatment: insulin.Outcome: recovered.A pharmaceutical technical complaint (ptc) was initiated on 15-may-2018 for synvisc with global ptc number: (b)(4) the production and quality control documentation for lot: 7rsa001zb expiration date (2019-12-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot: 7rsa001zb no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.As of 14-jun-18 there was only 1 complaint on file for lot: 7rsa001zb and all related sublots.1 complaint was on file for lot: 7rsa001zb: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.Seriousness criteria: hospitalization.Follow up information received on 15-may-2018.No new information received.Additional information was received on 14-jun-2018.Ptc results were added.Lot number was updated from 7rsa0012b to 7rsa001zb and expiry date was added.Text was amended accordingly upon internal review on 28-jun-2018, the company causality was updated from reportable to not reportable.Upon internal review on 09-jan-2019 processed with clock start date of on (b)(6)2018 the malfunction field previously captured as yes was removed.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 8200888
• MDR Text Key: 132388670
• Report Number: 2246315-2018-00842
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Lot Number: 7RSA001ZB
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention