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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SYSTEM; PROTHROMBIN TIME TEST STRIPS
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ROCHE DIAGNOSTICS COAGUCHEK XS SYSTEM; PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625374160
Device Problem High Test Results (2457)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Occupation is lay user/patient.The test strips were requested for investigation.This investigation is ongoing.
 
Event Description
There was an allegation of a questionable inr result with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.The result from the meter at 2:23 p.M.Was 5.5 inr.The result from the meter at 2:25 p.M.Was 5.5 inr.The result from the laboratory at 3:30 p.M.Was 3.8 inr.The patients therapeutic range is 2.0-3.0 inr.
 
Manufacturer Narrative
One strip from lot 449498-21 was returned for investigation where it was tested using a reference meter with a control sample, lot 47788900.Testing results: retention meter with customer strips: 2.6 inr.The obtained result was in the allowed range.No error message occurred during the investigation.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The returned and the retention material meet the specifications.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.".
 
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Brand Name
COAGUCHEK XS SYSTEM
Type of Device
PROTHROMBIN TIME TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key11417447
MDR Text Key246543274
Report Number1823260-2021-00654
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/23/2021
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
Device Operator Lay User/Patient
Device Expiration Date06/30/2021
Device Catalogue Number04625374160
Device Lot Number44949821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/04/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CALCIUM.; CLARITIN.; DEMANO POWDER.; FLONASE.; HYDROCORTISONE.; IBRANCE CHEMOTHERAPY DRUG.; LEVOTHYROXINE.; LORATADINE.; MAGNESIUM OXIDE.; METHANE.; METOPROLOL.; NYSTATIN.; PROPAFENONE.; WARFARIN.
Patient Age73 YR
Patient Weight98
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