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

Catalog Number	07453710001
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient woke up around 8:00 a.M.On (b)(6) 2024 and attempted to test his blood glucose level multiple times, but the blood glucose monitor kept displaying a test error message.The last time the patient successfully tested his blood glucose level was the night prior to the event and the result was 175 mg/dl.The patient took his normal medication of labetalol 100 mg, nifedipine 90 mg, and 20 units of unknown insulin on the morning of the event.These were normal medications that he takes each morning.The patient experienced symptoms of very shaky, drowsy, and numbness in his limbs at around 9:00 a.M.The patient was unconscious for a few hours.His cousin found him passed out and was able to wake him up enough to get him to the car where he was transported to the emergency room by his cousin.The patient arrived at the emergency room at around 12:00 p.M.And his blood level was 293 mg/dl.The patient was treated with an iv of unknown fluids.The patient was under observation and treatment for 4 hours.The patient was released from the emergency room at around 4:00 p.M.When his blood level was back to normal with a result of 163 mg/dl.
Additional Manufacturer Narrative
Device received in a condition which made analysis impossible.The returned test strips were previously used as there is a reddish-brown liquid residue inside the dosing window and insertion marking on the electrodes.

• 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: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 19812196
• Report Number: 3011393376-2024-01523
• Device Sequence Number: 12636750
• Product Code: NBW
• UDI-Device Identifier: 00365702710108
• UDI-Public: 00365702710108
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 06/12/2025
• Device Catalogue Number: 07453710001
• Device Lot Number: 104566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DULOXIN; LABETALOL; NIFEDIPINE; UNKNOWN INSULIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG