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 DIAGNOSTICS OPERATIONS INC COAGUCHEK XS PT TEST; TEST TIME PROTHROMBIN
  • 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 DIAGNOSTICS OPERATIONS INC COAGUCHEK XS PT TEST; TEST TIME PROTHROMBIN Back to Search Results
Model Number ROCHE COAGUCHEK XS PT TEXT
Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Coaguchek reported calibration problems with their int (pt) strips having inaccurate readings per letter (b)(6) dated (b)(6) 2018.Their solution was to send out more strips that were still not calibrated correctly.This resulted in several invalid readings of 7.5 and 7.9, well past the 4.5 allowable reading.This required a trip to the (b)(6) hospital, associated with (b)(6).This induced panic, emergency room visit to verify the results were valid or not, per the aforementioned letter from coaguchek.This problem should have been resolved in the beginning instead of sending more strips that had the same quality problem.This is inexcusable.They sent inr strips with a known problem to save their money, while passing the cost on to the (b)(6) hospital.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COAGUCHEK XS PT TEST
Type of Device
TEST TIME PROTHROMBIN
Manufacturer (Section D)
ROCHE DIAGNOSTICS OPERATIONS INC
MDR Report Key7978718
MDR Text Key124790326
Report NumberMW5080626
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/16/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/31/2019
Device Model NumberROCHE COAGUCHEK XS PT TEXT
Device Catalogue Number04625374160
Device Lot Number28124121
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age69 YR
Patient Weight75
-
-