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

Lot Number ASKU

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

Patient Problem Hyperglycemia (1905)

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

8.7/the event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that the patient received a 13 mg/dl result on the blood glucose monitor and experienced hyperglycemia symptoms of being pale and sweaty.The patient was transported to the hospital.The blood glucose result at the hospital was 310 mg/dl.The timeframe between the 13 mg/dl result and the 310 mg/dl result was not provided.The type of treatment provided to the patient was unknown.The patient was at the hospital for two hours.No further information was provided.

• Brand Name: ACCU-CHEK ® INSTANT 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 GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18744574
• MDR Text Key: 335816389
• Report Number: 3011393376-2024-00434
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female