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

Model Number 07398794001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 08/20/2022

Event Type  Injury  

Event Description

It was reported that the blood glucose monitor provided an electronic error message while the patient experienced hypoglycemia symptoms.On the day of the event, the patient felt sleepy in the morning and afternoon.The blood glucose monitor displayed the electronic error message in the morning.The patient did not give herself an insulin bolus on the day of the event due to the device being unavailable for use.She did not eat as normal because she was very tired.Around 6:30 p.M., the patient became incoherent and passed out.The patient's son contacted the paramedics.The blood glucose result was 36 mg/dl on the paramedic's meter.The patient was treated with unknown fluids via iv.The patient's blood glucose result was 195 mg/dl on the paramedic's meter before they left approximately 45 minutes to an hour later.The patient was not transported to the hospital.

• Brand Name: ACCU-CHEK ® GUIDE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; 13000 south memorial parkway; na; huntsville AL 35807
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 15349481
• MDR Text Key: 299180937
• Report Number: 3011393376-2022-02639
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702609105
• UDI-Public: 00365702609105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 07398794001
• Device Catalogue Number: 07398794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: LABETALOL; LOTREL; NOVOLOG INSULIN; UNKNOWN CONTINUOUS INSULIN PUMP
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 106 KG