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

Catalog Number 04625358019

Device Problem High Test Results (2457)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

During the time of the event, the patient allegedly used coaguchek xs meter serial number (b)(6) with test strip lot number 67192316 (expiration date = 31-jul-2024).The meter and strips were requested for investigation.A replacement product was sent.The product has not been received at this time and is not expected to be 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.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." after the reported event, the customer reported result discrepancies with the same device and this is documented in the medwatch with mfg report number 1823260-2023-02269.Section e3: occupation is patient/consumer.

Event Description

It was alleged that a patient had temporary paralysis that occurred sometime between (b)(6) 2023 and (b)(6) 2023 due to a blood clot in the brain.It was reported there were no changes in the patient's anticoagulation treatment during this time period.The patient was allegedly diagnosed with ischemic stroke and was treated with an unknown medication.The patient allegedly could not use the left side of their body temporarily and it took a week to recover.It was reported that the patient had no permanent damage.The patient's therapeutic range is reported to be 2.5 - 3.0 inr.The patient has been reportedly using the device for 9 months and tests weekly.

Manufacturer Narrative

The health effect - clinical code has been updated.

• 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 Key: 17357139
• MDR Text Key: 319379403
• Report Number: 1823260-2023-02362
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358019
• Device Lot Number: 67192316
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2023
• 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: ASPIRIN (1X1).; BETASERC (3X1).; EFEXOR (1X1).; NOOTROPIL (3X1).; VITARIN.
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 93 KG