Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK SMARTVIEW TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIABETES CARE, INC. ACCU-CHEK SMARTVIEW TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Model Number 06337546001
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/26/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 206 mg/dl, 226 mg/dl, 140 mg/dl (system 1) and 118 mg/dl (system 2).Readings were obtained with the same vial of test strips.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCU-CHEK SMARTVIEW TEST STRIPS
Common Device Name
BLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
MDR Report Key12422722
Report Number3011393376-2021-02715
Device Sequence Number3503870
Product Code NBW
UDI-Device Identifier00365702493100
UDI-Public00365702493100
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K113137
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date07/31/2022
Device Model Number06337546001
Device Catalogue Number06337546001
Device Lot Number479632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Initial Date Received by Manufacturer 08/27/2021
Supplement Date Received by Manufacturer09/28/2021
Initial Report FDA Received Date09/03/2021
Supplement Report FDA Received Date09/30/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
WARFARIN; WARFARIN
Patient Age62 YR
Patient Weight93
-
-