MAUDE Adverse Event Report: INTUITY MEDICAL, INC. POGO AUTOMATIC METER; BLOOD GLUCOSE METER

Model Number	00856176008001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation of the reported event, dhr, labeling and returned meter were performed.No issues were identified as part of the dhr and labeling review.Review of the event found that customer requested control solution which passed indicating both meter and the cartridges were functioning as intended at the time of the control solution test.Additional review of the reported event revealed that the customer was self-managing her diabetes despite having medical assistance prior to moving to her new senior living facility in (b)(6) 2020.The customer reports using vaseline on her hands as part of her method for milking blood to the tips of her fingers for testing.The customer reported taking 500 mg of metformin on the night of (b)(6) 2021 after her blood glucose test results were under 100 mg/dl.After this event her doctor lowered her prescription to 250 mg of metformin up to 2 times a day if blood glucose reading are over 110 mg/dl.The cartridges were not returned.Meter verification testing on the returned meter found the meter to be working as intended with no issues noted.When blood glucose readings were plotted on the clarke error grid the reading from the blood glucose meter not manufactured by intuity medical fell within zone b and would not make a clinical significance.Since her change in prescription, being advised not to use vaseline on her fingers before testing and receiving medical assistance at her senior living facility, she has not reported further issues.
Event or Problem Description
On (b)(6) 2021, the customer reported difficulties getting enough blood to test.Customer support (cs) provided techniques to stimulate blood flow such as running warm water over fingers and milking blood to fingertips.The customer requested control solution to verify that the meter and cartridge were working well together.Cs sent two replacement cartridges and an rma kit for the return of two cartridges for investigation.On (b)(6) 2021, the customer reported that the control solution test passed which indicates that the meter and cartridge were working as intended despite customer stating her results did not match how she felt.She also reported a previous reading of 38 mg/dl the prior weekend.The customer stated that on (b)(6) 2021, she tested using her normal technique of warming her hands with warm water and then milking her fingers using vaseline.She advised that on that night her blood glucose reading was lower than 100 mg/dl but she felt like it was over 100 mg/dl so she took 500 mg of metformin before bed.At this time her prescription was for 500 mg of metformin up to 2 times a day if blood glucose readings are over 100 mg/dl.When she woke up on (b)(6) 2021 she felt as if her blood glucose was low.She took butterscotch candy and juice to increase her blood sugar and called the emergency team at her senior living facility.The team tested her blood sugar using the pogo automatic meter which was 87 mg/dl and another blood glucose meter not manufactured by intuity medical with a result of 128 mg/dl.On (b)(6) 2021, the customer saw her doctor who lowered her medication to 250 mg of metformin up to 2 times a day if her blood glucose was over 110 mg/dl.The customer went up a level of care to receive medical assistance that will help her in taking blood glucose readings several times a day.Intuity medical's complaint handling representative advised customer to discontinue use of vaseline.As of date of this report, the customer has not reported any further issues.

• Brand Name: POGO AUTOMATIC METER
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): INTUITY MEDICAL, INC.; 3500 west warren ave; fremont CA 94538
• MDR Report Key: 11587091
• Report Number: 3013750448-2021-00001
• Device Sequence Number: 3697494
• Product Code: NBW
• UDI-Device Identifier: 00856176008001
• UDI-Public: 00856176008001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K181316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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 Model Number: 00856176008001
• Device Catalogue Number: 00856176008001
• Device Lot Number: 150339562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POGO CARTRIDGES MODEL #00856176008056 LOT M2011502
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 60