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

Model Number	701103
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected.Arkray attempted to gather information and request the return of subject meter.Actual product was not returned for testing and lot number is not known so retention samples could not be tested.If either strips or meter is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Caller could not see the lot number on the strips.Customer stated that she is getting inaccurate readings.Caller received 398 with inktel and claims that reading to be inaccurate.About a half hour before she said she received 38, and on the other hand received 512.Caller then took reading again and it was 259, then again it was 249 within a minute or so apart.Caller did not have any food, beverages, or medication before these results.Caller has not treated herself based on these results.Caller changes lancets for every test.No extreme temperature changes.Stores in bedroom.Meter is about 14 days old at most.Caller uses alcohol wipes and tests on the side of her finger.She does not have trouble getting a sample.No changes in diet or exercise.Strips are 50ct.Caller immediately replaces cap after removal of strip.Stores strips in bottle they come in.Walked through test and first test was 372 and second was 354.This is a 4.8% variance.Caller said she is sleepy and not feeling well.She is on diabetic neuropathy, high blood pressure, and aspirin for medications.Caller is insulin dependent and based on our meter she is unsure what to take for insulin because she says our meter is giving her varied readings.She is going into the er to find out what she should do.Please replace meter, 50ct strips, send cs, and rl.

• 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: 7842077
• Report Number: 1832816-2018-00017
• Device Sequence Number: 11154326
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: (01)00605388022936
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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 Model Number: 701103
• Device Catalogue Number: 701103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 59