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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.
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Type of DeviceINSULIN PUMP
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key9844907
MDR Text Key188327906
Report Number2243072-2020-00414
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
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 Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/17/2020 Patient Sequence Number: 1