MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD MINIMED PUMP; INSULIN PUMP

Catalog Number UNKNOWN

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

Patient Problems Bruise/Contusion (1754); Emotional Changes (1831); Hypoglycemia (1912); Overdose (1988); Pain (1994); Seizures (2063); Coma (2417); Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ minimed pump was used and the patient became hyperglycemic.This was discovered during use.The following information was provided by the initial reporter: ****litigation complaint****** material no: unknown batch no: unknown.Verbatim: after the patient refilled her insulin pump on the night of (b)(6) 2017, her pump and/or infusion set malfunctioned and delivered her pump¿s entire reservoir of insulin to her body at one time, causing her to become hypoglycemic.The patient has a service dog who has been trained to detect when her blood sugar is low.When her service dog alerted her, she checked her blood sugar and found it to be 36, at which point she drank some juice and ate some honey.She then lost consciousness and was in a diabetic coma for the remainder of the night.When she regained consciousness at 5:30 the next morning, she was disoriented and confused.Her movement was uncoordinated and her vision was impaired, causing her to determine she needed glucose treatment.She was also bruised and in pain.She had bitten her tongue and had multiple lacerations, indicating that she had experienced hypoglycemic seizures while she was unconscious.This made taking in hypoglycemia treatment difficult.When her blood sugar started to rise and her vision returned, she discovered additional injuries to her arm.Medical examination indicated that she had sustained orthopaedic, neurological, and muscle injuries, as well as psychological trauma and emotional distress.16.Upon information and belief, the minimed pump and infusion set which overdosed the patient malfunctioned as a result of defects that: failed to allow the reservoir to properly seat within the pump and allowed fluid to block the infusion set membrane during the priming, fill tubing process, which prevented the infusion set from working properly and causing an over-delivery of insulin.Injuries and damages sustained by the plaintiff, were both proximately caused and a reasonably foreseeable result of defendants¿ products and conduct.As a direct and proximate consequence of the defendants¿ conduct, the plaintiff sustained injuries and was damaged.

Event Description

It was reported that unspecified bd¿ minimed pump was used and the patient became hyperglycemic.This was discovered during use.The following information was provided by the initial reporter: ****litigation complaint****** material no: unknown.Batch no: unknown.Verbatim: after the patient refilled her insulin pump on the night of (b)(6) 2017, her pump and/or infusion set malfunctioned and delivered her pump¿s entire reservoir of insulin to her body at one time, causing her to become hypoglycemic.The patient has a service dog who has been trained to detect when her blood sugar is low.When her service dog alerted her, she checked her blood sugar and found it to be 36, at which point she drank some juice and ate some honey.She then lost consciousness and was in a diabetic coma for the remainder of the night.When she regained consciousness at 5:30 the next morning, she was disoriented and confused.Her movement was uncoordinated and her vision was impaired, causing her to determine she needed glucose treatment.She was also bruised and in pain.She had bitten her tongue and had multiple lacerations, indicating that she had experienced hypoglycemic seizures while she was unconscious.This made taking in hypoglycemia treatment difficult.When her blood sugar started to rise and her vision returned, she discovered additional injuries to her arm.Medical examination indicated that she had sustained orthopaedic, neurological, and muscle injuries, as well as psychological trauma and emotional distress.16.Upon information and belief, the minimed pump and infusion set which overdosed the patient malfunctioned as a result of defects that: (1) failed to allow the reservoir to properly seat within the pump and (2) allowed fluid to block the infusion set membrane during the priming, fill tubing process, which prevented the infusion set from working properly and causing an over-delivery of insulin.Injuries and damages sustained by the plaintiff, _________, were both proximately caused and a reasonably foreseeable result of defendants¿ products and conduct.As a direct and proximate consequence of the defendants¿ conduct, the plaintiff sustained injuries and was damaged.

Manufacturer Narrative

H.6.Investigation summary no physical sample or photos were returned for this investigation to date.The lot number of the device involved in this report is unknown therefore a dhr review could not be requested to support the investigation of this complaint.The complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future, the complaint record will be reopened for further investigation.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD MINIMED PUMP
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9844907
• MDR Text Key: 188327906
• Report Number: 2243072-2020-00414
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention