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

Model Number	GM01AAB
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated she was leaving an event yesterday and as she started walking towards her car, she started having a seizure.She stated that she didn't feel low and the meter that she has read 90 and so medically she shouldn't have been having a low blood glucose seizure, but she did.Customer stated her doctor said unless it was something undiagnosed that would be the only thing that would have caused it, so they made adjustments, and everything seemed to balance out and was still good this morning so she was driving home and she stopped to get gas and started having another seizure and the meter read 72 and she stated again that is not low enough to cause a diabetic seizure.Another concern of hers yesterday was that she stated after having over 100 grams of carbohydrates, about 30 minutes after the reading of 90, she still was testing at only 98 and that is a lot of carbs and she feels like it should have been higher, and then even another 30 minutes later, it was still only at 108.Caller stated she is feeling fine now but she has concerns that there is something wrong with the meter and/or strips and she can't trust the meter she has now.Caller stated she had had this same thing happen with the sensor brand and therefore she switched back to the relion brand, but she feels the readings she is receiving on the relion meter are grossly inaccurate.Rep offered to go through back-to-back testing with the caller for comparison testing, but the caller stated she only has one test strip left.Caller stated she was going to go and get more strips, but before she did that she wanted to know if she should just pick up a new meter too while she was there.Rep offered to send a replacement meter and strips and customer stated she was just going to go and pick up a new meter and strips.Rep then requested customer to give us a call back for comparison testing and gave customer the direct number to give us a call back.We did send a replacement meter and strips to the customer as well.Attempted to contact customer twice to gather more information not included in this incident report but was unable to reach the customer again.
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of the incorrect readings using a meter of the retained meter and strips of the same lot.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%) which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.

• Brand Name: RELION PREMIER BLU BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• Manufacturer (Section G): I-SENS WONJU FACTORY; 94-1, donghwagongdan-ro; munmak-eup; wonju-si, 26365 ; KS 26365
• Manufacturer Contact: hyojin baik ; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 15468614
• Report Number: 3005621222-2022-00016
• Device Sequence Number: 16873536
• Product Code: NBW
• UDI-Device Identifier: 00681131285742
• UDI-Public: (01)00681131169806,(01)00681131285742
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: 01/26/2024
• Device Model Number: GM01AAB
• Device Catalogue Number: 782001
• Device Lot Number: TD27BBLYD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown