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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Ischemia Stroke (4418)

Event Date 08/18/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation is patient/consumer.The meter and test strips were requested for investigation.The meter and strips were provided for investigation where they were tested using a high-level control sample.Testing results (qc range = 4.1¿ 6.8 inr): qc 1: 5.1 inr, qc 2: 5.2 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 meter result from (b)(6) 2022 was observed in the meter¿s patient result memory.There were two additional results of 4.2 inr on (b)(6) 2022.Prior to (b)(6) 2022, the alleged results and dates cannot be confirmed as the date appeared to be set incorrectly in the meter.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.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.

Event Description

There was an allegation of questionable inr results occurring on (b)(6) 2022 with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.The inr results from the meter were being questioned as the patient allegedly had a stroke on (b)(6) 2022.The patient¿s therapeutic range is allegedly 2.0 ¿ 3.0 inr with a reported testing frequency of once a week.On (b)(6) 2022, the meter result was reportedly 2.0 inr at 10:08 a.M.This result was reported to his physician but the patient could not remember if his jantoven dose was adjusted.The patient believed his jantoven dosage would have been kept the same (5 mg for six days and 2.5 mg one day) based on the meter result.On (b)(6) 2022 at 7:00 a.M.The patient reportedly took an unspecified dosage of jantoven.Sometime "later" as he was driving he realized his speech was beginning to slur.The patient reportedly drove himself to the nearest emergency room.On (b)(6) 2022 at 8:37 a.M.The patient was admitted and the result from an unknown method was reportedly 1.83 inr.The patient had a computed tomography (ct) test and "eventually" he was reportedly unable to speak.Allegedly, no treatment was provided at this hospital; only diagnostic testing was performed.The patient was reportedly transferred to a larger hospital by ambulance.At the second hospital, the patient was reportedly tested by ct again.The ct allegedly showed a clot that was originally observed around the speech center of his brain.Fluoroscopy was reportedly performed in preparation for a thrombectomy, however, the clot could not be found.Another ct was allegedly performed and the clot still could not be found.Magnetic resonance imaging (mri) was reportedly performed to confirm a dead zone where the clot had originated.The doctors reportedly believed the clot moved to an unknown position or it spontaneously dissolved.A transthoracic echo and a transesophageal echo were also reportedly performed.The patient was allegedly in the intensive care unit (icu) for 2 days.The patient reportedly began speaking approximately 16 hours after being admitted.The patient did not know what treatment he received in the hospital.The patient believes he was on a heparin drip "at first" and was then on warfarin on (b)(6) 2022.The patient was reportedly released from the hospital on (b)(6) 2022 and reportedly began lovenox at home.On (b)(6) 2022 the patient¿s doctor allegedly had him come in for observation to make sure he was using the coaguchek xs meter correctly.The doctor reportedly believed the patient was using the meter correctly and scheduled a laboratory test for (b)(6) 2022.On (b)(6) 2022 the result from the meter was reportedly 3.6 inr at 7:09 a.M.The result from the laboratory using an unknown method was reportedly 2.75 inr at 10:33 a.M.The patient had reportedly been bridging with lovenox from (b)(6) 2022.Prior to the stroke on (b)(6) 2022, the patient had been on vacation and had reportedly been eating more sporadically and was more active.The patient is currently feeling "pretty well.".

• 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: 15554460
• MDR Text Key: 301347799
• Report Number: 1823260-2022-03082
• 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
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 60124922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/06/2022
• 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: CHOLESTYRAMINE,; CROMOLYN SODIUM,; FAMOTIDINE,; GABAPENTIN,; GLUTAGENICS,; JANTOVEN,; LORATADINE,; MAGNESIUM GLYCINATE,; MELOXICAM,; N-ACETYLCYSTEINE,; OMEGA-3 FISH OIL,; PALMITOYLETHANOLAMIDE,; POLYRESVERATROL SR,; PROBIOTIC,; ROSUVASTATIN CALCIUM,; SERUM DERIVED BOVINE,; TERRY NATURALLY HEALTHY FEET AND NERVES VITAMIN,; VITAMIN C.; VITAMIN D3,
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 79 KG