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

Catalog Number	08053723001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received a blood glucose result of 138 mg/dl at 3:02 p.M.And he experienced hypoglycemia symptoms of feeling shaky, weak, and sweaty.The patient was unable to self-treat and his wife provided glucose tablets, chocolate milk, and soda.At 3:16 p.M., the blood glucose monitor displayed a result of 125 mg/dl.The patient tested on his continuous glucose monitor and the result was 58 mg/dl.His competitor meter displayed a 49 mg/dl result at the same time.The patient was very tired and slept for a few hours.

• Brand Name: ACCU-CHEK ® GUIDE 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: 18094753
• Report Number: 3011393376-2023-02508
• Device Sequence Number: 6753989
• Product Code: NBW
• UDI-Device Identifier: 00365702726109
• UDI-Public: 00365702726109
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Expiration Date: 07/05/2024
• Device Catalogue Number: 08053723001
• Device Lot Number: 103827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 780G PUMP.; CONTINUOUS BLOOD GLUCOSE MONITOR.; GLUCOPHAGE.; HUMALOG INSULIN.; UNKNOWN COMPETITOR BLOOD GLUCOSE MONITOR.
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 116 KG