MAUDE Adverse Event Report: ARKRAY FACTORY, INC. RELION PRIME BLOOD GLUCOSE TEST SYSTEM

Model Number	701102
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned and evaluated and performed to specification.Retain strips were also tested with returned meter and performed to specification.No failure detected.
Event or Problem Description
Arkray received this complaint through the fda's medwatch program and then followed up with the customer to gather more details.The patient ran out of her normal glucometer test strips (freestyle lite), which she has used for many years without issues, while she was on vacation.Patient tried to by replacement test strips over-the-counter, but they were cost prohibitive for 100 strips at the local pharmacy.Instead they purchased a relion prime meter and test strips.Caller wants to report this glucometer because they feel it is dangerously unreliable.They are certain the readings are inaccurate, as the readings routinely read either less than 50 or greater than 500.The patient occasionally has such extreme values, but not with this frequency.The caller is even more concerned about the imprecision of the device, because when they checked the patient's blood three times in one sitting, the numbers fluctuate tremendously.For example, one evening the meter read 467, 378, and 515 within the span of five minutes.Clearly the patient's blood glucose level did not change so drastically during those few minutes.These kinds of variable results were received multiple times.Because of this, it made it extremely challenging to dose her humalog.On the first day we had the relion prime meter, we gave her far too much insulin and her glucose level fell very low, requiring multiple juice boxes and cereal bars to get her back to a safe level.For the remainder of the vacation, we learned that we needed to take readings multiple times, average it, and hope the average is accurate.Controls were not used.Refund was provided to the customer.

• Brand Name: RELION PRIME BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 7545598
• Report Number: 1832816-2018-00006
• Device Sequence Number: 11082008
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: (01)00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/16/2019
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 031218D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/25/2018
• 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; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 54