MAUDE Adverse Event Report: I-SENS INC. RELION PREMIER BLU TEST STRIPS; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	RELION PREMIER BLU TEST STRIPS
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the customer had thrown away the complaint strip bottle and only given lot information of strip, i-sens analyzed the cause of defective packaging using with retained test strip bottles.As a result of investigation, all retained strip bottles of specified lot were properly packed and the desiccants did not come out of the cap when test strip bottles were opened.In addition, there was no particular matters found as the device history record was reviewed.
Event or Problem Description
Customer called he said that the cap on the strip bottle broke when he tried to open it and desiccant spilled all over his bed.He called poison control and they said that it was a drying agent.He said that it flew all over and some may have gotten in his face.There was no damaged to the bottle prior to opening.He has not reused bottle.The beads are very small, so he is concerned about the possibility of remaining desiccant around his home.His major concern was that there was not anything that could have been poisonous within the desiccant.He was not given a direct answer as to what the desiccant is, and the people he spoke to acted like it was no big deal.He feels that it was not properly sealed and that is what lead to the desiccant falling out of the bottle cap.He feels that there should be something in the insert or literature about what the desiccant/chemical for any other issues that may happen in the future.The distributor explained that the bottles were purchased from a third party.Replaced strip and sent return label.The msds for the desiccant was sent to the customer on (b)(6) 2019.

• Brand Name: RELION PREMIER BLU TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS INC.; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 9096609
• Report Number: 3005621222-2019-00008
• Device Sequence Number: 2830918
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K170614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/09/2021
• Device Model Number: RELION PREMIER BLU TEST STRIPS
• Device Catalogue Number: 780100
• Device Lot Number: QD10BBL6F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 159