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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 03/17/2022

Event Type  Injury  

Event Description

The reporter called to ask if coaguchek xs meter serial number (b)(4) needed to be recalibrated, was eligible for replacement and what the life expectancy of the meter was due to an "emergency event last month" when the patient¿s inr dropped very low.On (b)(6) 2022 the patient allegedly had a stroke.The result at the hospital on (b)(6) 2022 from an unknown laboratory method was 1.4 inr.On (b)(6) 2022, while the patient was still in the hospital the patient tested on his meter with a result of 1.6 inr.The result from the hospital laboratory was reportedly "close to that level" but the specific result was not provided.In the hospital, the patient's warfarin dose was reportedly increased slightly from 5 mg to 6.5 mg.The patient was reportedly in the hospital for 9 days.A blood clot was reportedly found on the right side of his brain by computed tomography (ct) scan.The patient allegedly had 4 ¿ 5 ct scans during his hospital stay.The patient was reportedly going to have surgery through his groin to take care of the clot, but allegedly that did not work.The patient was reportedly treated with a clot-busting drug.The reporter was not sure of the name of the drug, but thought it might be tissue plasminogen activator (tpa).The drug was reportedly successful in taking care of the clot.Neither the patient or the patient¿s doctor are sure what led to the stroke.The patient has reportedly never had issues with the meter results.The patient reportedly tested on the meter "a few days prior" to the stroke and his warfarin dose was not changed because the result was within his therapeutic range.The patient was allegedly taking 5 mg warfarin at that time.The patient stated he may have missed taking a dose of warfarin in the days prior to the stroke but he is not sure if he did.The patient had reportedly been eating differently (eating more steak) while traveling for a conference.The most recent meter result from the patient¿s logbook was reportedly 2.5 inr on (b)(6) 2022.The patient¿s therapeutic range is allegedly 2.5 ¿ 3.5 inr and the patient tests weekly.

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation.The meter was returned for investigation; the test strips were not returned.The meter was tested using retention strips and retention controls: testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.3 inr, qc 2: 5.1 inr, qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The alleged results were not observed in the meter memory as the meter memory was erased by the patient prior to returning the device.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." the investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The device code was updated.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14345928
• MDR Text Key: 291293202
• Report Number: 1823260-2022-01340
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 51508621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• 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 Number: 1
• Treatment: ATORVASTATIN; EZETIMIBE; LISINOPRIL; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG