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

Catalog Number 04625374160

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(6) compared to a laboratory using an unknown reagent.At 11:21 am, the meter result was 5.2 inr.The same finger was used for this test that was used for a previous fingerstick.At 12:53 pm, the meter result was 5.7 inr.At approximately 2:00 pm, the result from the laboratory was 3.8 inr.Customer's therapeutic range is 2.0-3.0 inr.

Manufacturer Narrative

E3: occupation is patient/consumer (son reported).The test strips were requested for investigation.The product has not been returned.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.Customer reported receiving error 5 during testing.Error 5 is caused by not applying adequate sample to the test strip which was confirmed by the reporter.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 origin (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." the investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

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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 Key: 16809963
• MDR Text Key: 314094401
• Report Number: 1823260-2023-01401
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 63658921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/23/2023
• 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 Number: 1
• Treatment: WARFARIN
• Patient Sex: Male