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 Hypoglycemia (1912)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

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

The caller reported that the blood glucose device gave an incorrect reading, based on how he was feeling.The caller stated that he received a blood glucose result of 128 mg/dl, however he experienced symptoms of feeling dizzy and did not feel this reading was correct.The caller was not sure what happened next, but reported that he woke up in the hospital.No further information about the event could be 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: 18520066
• MDR Text Key: 332945714
• Report Number: 3011393376-2024-00144
• 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: 02/29/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male