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

Model Number	701103
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
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 stated on (b)(6) 2017 her prime meter gave her a false high reading and she went to the emergency room because of it.(b)(4).Test strips that were involved in the incident have all been used, the bottle has been thrown away, so the customer does not know the lot number of these strips.When doing her blood tests, she does use proper technique except for the fact she presses the test strip directly to her finger.I informed her about the test strips acting like a straw and the suction may get blocked by pressing the test strip directly to her finger.She went into the hospital due to her reading being 419.Her normal range is anywhere from 80-120.She felt dizzy, nauseous, lethargic, and her vision was blurred.Her symptoms did not match the reading.These symptoms are the symptoms she feels with low readings, not high ones.She did not treat herself based on this reading, but called the hospital and was advised to come in immediately.At the hospital, they poked her finger and received a reading of 130, whereas the blood glucose reading from the blood draw for the lab was 120.The doctor told beth to contact us as there may have been a malfunction with the products.She was not treated at the hospital.She went home and symptoms were resolved once she ate.Beth does wear a cpap at night, but does not undergo further oxygen treatment.She stores the meter and strips together in her living room away from electronics.Meter and strips are in good condition, meter has not been dropped, and both meter and strips have not been exposed to extreme temperatures or moisture.Controls were not used as the caller does not have control solution.Replaced meter, test strips, and sent return label.
Additional Manufacturer Narrative
Meter involved in incident was returned without strips and lot number is not known.Returned meter and reference strips were evaluated and performed to specification.No failure detected.

• Brand Name: RELION PRIME BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY, INC.; 57 nishiaketa-cho; higashi-kujo, minami-ku; kyoto 601-8045, ; JA
• MDR Report Key: 7231296
• Report Number: 1832816-2018-00003
• Device Sequence Number: 13692483
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: (01)00605388022936
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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,Followup
• Report Date (Section B): 01/06/2018

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 Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2018
• Supplement Date Received by Manufacturer: 01/06/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/08/2018
• 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: Hospitalization; Life Threatening
• Patient Age: 48 YR
• Patient Weight: 128