MAUDE Adverse Event Report: ANIMAS LLC ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Medical Device Problem Codes	Partial Blockage (1065); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07-jun-2018 with the following findings: during the investigation, a review of the device history showed the last basal delivery was on (b)(6) 2018.The black box history showed an occlusion alarm with high force on (b)(6) 2018 at 01:37, with delivery resuming at 02:01.An occlusion alarm with high force was also observed on (b)(6) 2018 at 05:28, with deliveries resuming at 05:37.Multiple occlusion alarms were also observed in the alarm history on (b)(6) 2018.The pump¿s rewind, load cartridge, and prime steps were performed successfully with no alarms.The pump was found to be detecting the correct force.The pump was exercised for 24 hours with no occlusions occurring.The pump¿s total daily dose added up correctly and reflected the users programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.The pump¿s cover was removed, and no intermittent condition was found to the force sensor circuit.
Event or Problem Description
On (b)(6) 2018 the patient contacted animas alleging a blood glucose level greater or equal to 500 mg/dl accompanied with no other symptoms of hyperglycemia.The patient alleged they experienced high blood glucose in the 400 mg/dl range, and sometimes even higher.Reportedly, the pump had reoccurring occlusion cs 064 (occlusion) alarms following the changing of the site 4-6 times.Trouble shooting revealed the patient was unable to prime the pump without a cs 064 call service alarm occurring.Trouble shooting revealed the patient was over cycling the cartridges.This complaint is being reported because it is associated with use error from over cycling the cartridges along with the alleged frequent/persistent call service 064 alarms that could have caused or contributed to the patient¿s alleged hyperglycemic event.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7591455
• Report Number: 2531779-2018-10763
• Device Sequence Number: 19286109
• Product Code: LZG
• UDI-Device Identifier: 10840406101034
• UDI-Public: 10840406101034
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 59 YR
• Patient Weight: 210