MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® RELION TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Model Number	09409971001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product no longer available for return.
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 419 mg/dl and 101 mg/dl.The patient reported that he finished up eating dinner and did not wash his hands prior to testing.The patient stated that he "may" have had some enchilada sauce on his finger.He washed his hands and retested with the 101 mg/dl result.

• Brand Name: ACCU-CHEK ® RELION TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 16432109
• Report Number: 3011393376-2023-00495
• Device Sequence Number: 5297895
• Product Code: NBW
• UDI-Device Identifier: 00681131403276
• UDI-Public: 00681131403276
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K203711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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: 09409971001
• Device Catalogue Number: 09409971001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 81 KG