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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® GUIDE TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® GUIDE TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 07453744001
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2024
Event Type  malfunction  
Event Description
It was reported the patient received the following results within 15 minutes: 211 mg/dl and 96 mg/dl.
 
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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 Key18984902
MDR Text Key338729909
Report Number3011393376-2024-00725
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00365702712102
UDI-Public00365702712102
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160944
Number of Events Reported1
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 Received03/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number07453744001
Device Lot Number104586
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2024
Is the Device Single Use? No
Patient Sequence Number1
Treatment
ATENOLOL 50 MG; ELIQUIS 2.5 MG; FENOFIBRATE 54 MG; SYNTHROID 1.50 MG; UNKNOWN INSULIN 140 UNITS
Patient Age67 YR
Patient SexFemale
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