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

Catalog Number 07453736001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fatigue (1849)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported the patient received the following results within 15 minutes: 545 mg/dl, 585 mg/dl, 127 mg/dl , 459 mg/dl, and 95 mg/dl.At this time, customer had a headache, felt weak, and tired.No treatment was needed.

• Brand Name: ACCU-CHEK ® GUIDE TEST STRIPS
• Type of Device: 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: 18976982
• MDR Text Key: 338546983
• Report Number: 3011393376-2024-00708
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702701953
• UDI-Public: 00365702701953
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07453736001
• Device Lot Number: 104598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2024
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 20 KG