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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 Low Test Results (2458)
Patient Problems Bruise/Contusion (1754); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2023
Event Type  Injury  
Manufacturer Narrative
The meter and strips have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.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." initial reporter - occupation was patient/consumer.
 
Event Description
There was an allegation of questionable results from a coaguchek xs meter.The serial number was requested but was not known.The result from the meter, possibly in the morning, was allegedly 2.2 inr.The result from the hospital laboratory when he arrived was reportedly 4.7 inr using an unknown reagent.The actual time between the meter and laboratory testing could not be provided.The therapeutic range was 2.5-3.5 inr.Additional information was requested but the reporter refused to provide any further information.
 
Manufacturer Narrative
Medwatch fields b1, b2, and h1 were updated.
 
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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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key16620887
MDR Text Key312063139
Report Number1823260-2023-00974
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702127104
UDI-Public00365702127104
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062925
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 03/31/2023
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 Catalogue Number04625374160
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/23/2023
Initial Date FDA Received03/27/2023
Supplement Dates Manufacturer Received03/31/2023
Supplement Dates FDA Received03/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexMale
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