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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST; PROTHROMBIN TIME TEST STRIPS

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ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST; PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625358003
Device Problem Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2022
Event Type  malfunction  
Event Description
We received an allegation of questionable inr results for one patient tested on a coaguchek xs meter compared to an unknown laboratory methodology.On (b)(6) 2022, at 11:00 a.M., the laboratory result was 2.41 inr.On (b)(6) 2022, at 12:20 a.M., the patient's inr result on the coaguchek xs meter was 1.7 inr.The patient's therapeutic range was requested but not provided.The serial number of the coaguchek xs meter was requested but was not provided.
 
Manufacturer Narrative
The customer material was requested for investigation.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 the results have passed the internal inspection.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origins (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared to other laboratory methods.".Reporter: occupation is patient/consumer.
 
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Brand Name
COAGUCHEK XS PT TEST
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 Key15598826
MDR Text Key307112637
Report Number1823260-2022-03147
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/13/2022
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 Number04625358003
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/16/2022
Initial Date FDA Received10/13/2022
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
Treatment
ALDACTAZID; ALYSE; BELOK; CITOLES; CODIVAN; COUMADIN; DESAL; GALLUS; GLIFOR; LIBOXIN
Patient Age79 YR
Patient SexFemale
Patient Weight57 KG
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