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

Model Number	701103
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was using incompatible strips, which is a user error, which lead to this adverse event.Dhr review not required.Retain testing not required.Actual product was not returned for testing.If meter is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Reporter said the meter was giving the "wrong" blood sugar readings.Reporter found out that the strips she has aren't compatible the prime meter.Customer purchased one touch ultra test strips on approximately (b)(6) 2019 and began using them in his prime meter.Reporter thinks it was (b)(6) that patient went to the hospital.When he got there his sugar was at 800 and he was in the hospital from (b)(6).They released him because his sugar levels went down.He hadn't been feeling well and stayed home monday, tuesday, wednesday and on thursday (b)(6) he took a reading and received 67.He had a scheduled doctor's appointment that morning at 8:40 and received a reading of 500(something) and they sent him back to the hospital.Caller has two bottles of one touch ultra test strips lot number 4549961, expiration 2020-12-31, 50ct.Arkray informed the reporter to not use any more of those test strips with the meter and then informed the customer of the correct test strips to use with the relion prime meter.The reporter said that the patient was receiving readings of 197, 168, 154, 127.The reporter then stated it was reading low.Reporter also stated he received a reading of 53 and he thought he needed to eat because he was low, but he was eating the wrong thing and hurt himself.The reporter then stated, "they had to make the patient go to the hospital, because they could tell he wasn't quite right" and he was initially refusing to go to the hospital because he was trusting the meter.He just lost 20 pounds in the last couple of weeks.Typical blood glucose readings are around 120-130.The reporter stated she "doesn't know why he got those test strips, and she thinks he got them right before going to the hospital".Arkray confirmed with the reporter that the patient inadvertently purchased the incorrect test strips.Replaced meter, sent correct strips and sent return label.
Additional Manufacturer Narrative
Meter involved in incident was returned for evaluation.Meter was evaluated with reference strip lot 032019b, expiration 2020-10-29, and performed to specification.No failure detected.

• Brand Name: RELION PRIME BLOOD GLUCOSE 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: 9371772
• Report Number: 1832816-2019-00028
• Device Sequence Number: 2578549
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: (01)00605388022936
• 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,Followup
• Report Date (Section B): 12/11/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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: 65 YR
• Patient Weight: 73