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

Model Number	701103
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected.Meter involved in incident was returned.Meter and retain strips were evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller is reporting blood variable results.Caller has owned meter for one month.Caller called having some problems getting readings to register.Went through technique and found that meter is placed on the table when applying blood and caller puts hands around it to apply to the sample.Attempted to explain how to properly hold the meter.Afterward, caller stated that the meter's back cover was off where the battery is located and she was having trouble getting meter to work.Later found that meter wasn't damaged/dropped but caller has been unable to get cover to stay on.She later stated that she ended up in the hospital yesterday as a result of some extreme lows and extreme highs in her readings.Caller stated she is getting variable readings; meter is testing high, but her blood sugar is actually low, or her meter is reading low, but her blood sugar is actually high.Caller was very dizzy and she fell.Treatment specifications were not given by the caller.She just said they wanted to monitor her levels but did not specify on any meds given or anything else that was done to bring levels back up to where they should be.She didn't wish to stay on the phone longer to specify so i took down her summary of events the best i could.She was released today from the hospital and was advised to get another meter.Caller didn't want to stay on the line with me that long and was getting anxious to get off phone.I was unable to understand some of the things she said when she listed her medications so i did my best to list what i could hear.She has type 1 diabetes and is insulin dependent.Caller is also pregnant.Caller is also undergoing oxygen therapy.It sounded like she was at least changing out lancet/properly washing hands, etc.Caller was unable to provide me with date/time on the readings, stating she couldn't see the dates but did give me some examples of readings she was getting.Since caller was not sure about how long it would take to receive replacements, i had her ask (b)(6) pharmacy if they'd do them off the shelf.Pharmacist agreed to that.Please send replacement meter, 25 ct strips, and rl to: (b)(6) pharmacy will take care of sending back old meter/strips.Please send customer cs.Controls not used.

• Brand Name: RELION PRIME BLOOD GLUCOSE SYSTEM
• Common Device Name: RELION PRIME BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): ARKRAY, INC.; 57 nishiaketa-cho; higashi-kujo, minami-ku; kyoto 601-8045, ; JA
• MDR Report Key: 6559676
• Report Number: 1832816-2017-00003
• Device Sequence Number: 16176501
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: 00605388022936
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/13/2017

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: 07/31/2018
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 030917C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/11/2017
• 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; Required Intervention
• Patient Age: 37 YR