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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
Model Number 08256292001
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Chest Pain (1776)
Event Date 05/14/2021
Event Type  malfunction  
Event Description
It was reported the patient received the following results within 15 minutes: 381 mg/dl and 118 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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key11876810
MDR Text Key252400376
Report Number3011393376-2021-01599
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00365702719101
UDI-Public00365702719101
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 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/28/2021
Device Model Number08256292001
Device Catalogue Number08256292001
Device Lot Number101829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received06/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2020
Is the Device Single Use? No
Patient Sequence Number1
Patient Age77 YR
Patient Weight86
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