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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 06454011052
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2024
Event Type  malfunction  
Event Description
It was reported the patient received the following results within 15 minutes: 550 mg/dl and 233 mg/dl.
 
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.
 
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Brand Name
ACCU-CHEK ® PERFORMA 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 Key18994727
MDR Text Key338905723
Report Number3011393376-2024-00732
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number06454011052
Device Lot Number671148
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2024
Is the Device Single Use? No
Patient Sequence Number1
Patient SexFemale
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