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

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	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter and test strips were returned and evaluated.Customer returned four bottles of strips of specified lot.Returned meter and bottle 1 strips failed testing on all three levels by generating low results confirming the complaint.Retain strips tested with returned meter and passed testing indicating this is a strip issue.Returned strip bottles 2 and 3 also passed testing with returned meter.Bottle 4 was full, with 50 test strips, so was not required to be tested.Additional investigation was done to assess integrity of the desiccant in the returned bottle 1.Results showed that the desiccant was not compromised.There was also a physical defect finding of lcd display leaking ink.Product will be returned to the manufacturer for further evaluation.Arkray usa experienced issues filing this mdr (see fda ticket 194252) which is why it is filed late.
Event or Problem Description
Caller indicated the relion prime meter was giving variable readings.It appears to be with a new bottle of strips.Caller has three meters, and all are doing the same with this lot.Strips are kept in dining room.Keeps strips in the original bottle.He tried a different bottle and received a 156 then tested the bottle he claims getting lo and received 65.All four bottles of strips have the same lot number.Replaced system and sent return label to send products back for testing.

• Brand Name: RELION PRIME BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 8988134
• Report Number: 1832816-2019-00016
• Device Sequence Number: 16976898
• Product Code: NBW
• UDI-Device Identifier: 00605388022943
• UDI-Public: (01)00605388022936,(01)00605388022943
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/09/2019

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 Expiration Date: 12/17/2020
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 050919B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1