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

Catalog Number	07797826160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
K.N 12/22/2022 the reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.The result from the meter was 2.3 inr.The result from the laboratory was 1.8 inr.On (b)(6) 2022 at approximately 5:04 pm, the meter result was 2.6 inr.The result from the laboratory was 2.0 inr.On (b)(6) 2022 at 4:15 pm, the result from the meter was 3.1 inr.The result from the laboratory at the same time was 2.3 inr.The patient's therapeutic range was unknown.
Additional Manufacturer Narrative
The test strips were requested for investigation.The reporter¿s strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.8 inr, qc 2: 2.8 inr, qc 3: 2.7 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Customer is wiping away the first drop of blood and applying the second drop of blood.They stated they often squeeze the finger a lot to get the second blood drop.Per product labeling, "if needed, immediately after lancing, gently massage the finger from its base until a drop of blood is formed.Do not press or squeeze the finger." 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.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.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: PROTHROMBIN TIME MONITOR
• 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: 15382266
• Report Number: 1823260-2022-02758
• Device Sequence Number: 5707403
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 07797826160
• Device Lot Number: 58943516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; HYDROXYZINE; IRON; MIRTAZAPINE; WARFARIN
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG