MAUDE Adverse Event Report: UNOMEDICAL A/S ROCHE ACCU-CHEK TENDERLINK; INSULIN INFUSION SET - TYPE COMFORT

Model Number	4541600001
Health Effect - Clinical Codes	Hyperglycemia (1905); Cramp(s) (2193); Loss of consciousness (2418)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Presently (25apr2019) no root cause can be determined.Unomedical is trying to obtain further, relevant information on the incident.No used set has been returned and an infusion set failure cannot be confirmed.By presently available data causality remains unclear.In particular, the absence of a pump alarm ('no delivery') may indicate that the infusion set was not occluded.A visual inspection and tests for flow and leak were performed on the returned unused devices (9 sets).All test results were within specifications.The lot reference samples were visually inspected and tested for flow and leak.All test results were within specifications.The batch record 5227999 was verified and found within specifications.
Event or Problem Description
(b)(4).(b)(6) - incident data from a roche diabetes care communication to unomedical.(b)(4): on (b)(6) 2019 customer inserted an ac tenderlink 13mm/60cm; after 5-6 hours blood glucose value increased to up to 500 mg/dl.On (b)(6) 2019 at 01:00 a.M.Blood glucose value was 360 mg/dl.Correction via syringe.In the night the roommate found the customer unresponsive/unconscious with cramps in his bed.The roommate called the emergency doctor.Customer got an infusion (unknown) and was driven to the (b)(6).Released from the hospital on (b)(6) 2019 after receiving the replacement pump.Now everything o.K.The customer noticed that there was a leak at the soft cannula and the needle was bent.Furthermore customer assumes the pump doesn't deliver insulin correctly and pump makes abnormal noises.
Event or Problem Description
Unomedical reference is (b)(4).Translated from german: incident data from a roche diabetes care communication to unomedical.Roche reference is (b)(4): on (b)(6) 2019 customer inserted an ac tenderlink 13mm/60cm; after 5-6 hours blood glucose value increased to up to 500 mg/dl.On (b)(6) 2019 at 01:00 a.M.Blood glucose value was 360 mg/dl.Correction via syringe.In the night the roommate found the customer unresponsive/unconscious with cramps in his bed.The roommate called the emergency doctor.Customer got an infusion (unknown) and was driven to the (b)(6).Released from the hospital on (b)(6) 2019 after receiving the replacement pump.Now everything o.K.The customer noticed that there was a leak at the soft cannula and the needle was bent.Furthermore customer assumes the pump doesn't deliver insulin correctly and pump makes abnormal noises.
Additional Manufacturer Narrative
Presently (25apr2019) no root cause can be determined.Unomedical is trying to obtain further, relevant information on the incident.No used set has been returned and an infusion set failure cannot be confirmed.By presently available data causality remains unclear.In particular, the absence of a pump alarm ('no delivery') may indicate that the infusion set was not occluded.A visual inspection and tests for flow and leak were performed on the returned unused devices (9 sets).All test results were within specifications.The lot reference samples were visually inspected and tested for flow and leak.All test results were within specifications.The batch record 5227999 was verified and found within specifications.Update per 20-may-2019: it has not been possible to obtain further incident data.Taking into account the remark that after pump replacement 'everything is o.K.' we assume it to be likely that a pump malfunction caused the incident, and that the observation of a bent cannula is incidental.Moreover, should a cannula be so bent that the insulin fluid path becomes obstructed the pumps occlusion alarm should alert the patient.Should any new, relevant information become available we will re-assess the incident and inform fda by a new follow-up mdr submission.

• Brand Name: ROCHE ACCU-CHEK TENDERLINK
• Common Device Name: INSULIN INFUSION SET - TYPE COMFORT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• MDR Report Key: 8548637
• Report Number: 8021545-2019-00002
• Device Sequence Number: 10852807
• Product Code: FPA
• UDI-Device Identifier: 05705244008502
• UDI-Public: 05705244008502
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Model Number: 4541600001
• Device Lot Number: 5227999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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: Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Weight: 84