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

Catalog Number 04625374160

Device Problems Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/04/2022

Event Type  Injury  

Manufacturer Narrative

The meter and test strips were requested for investigation and have not been received at this time.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 the results have passed the internal inspection.  per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods."  the patient stated that he was unable to test for a month due to errors on the meter.The reporter was advised on the call that if they are unable to test due to an error or the meter not functioning to call roche technical service right away or to contact their physician.Product labeling states: "you may see the following error messages while using the coaguchek xs meter.If you see an error message, first try to correct the problem using the solution described below.If the problem persists, call the roche customer support center at 1-800-428-4674, monday through friday from 7 am to 11 pm est." the patient stated that he received an error 5: product labeling states: "error: blood application error 5 - error applying blood to the test strip.Solution: turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger." the patient has anemia with a hematocrit of 23.8%.Product labeling states: "hematocrit ranges between 25-55 % do not significantly affect result." occupation is patient/consumer.The reporter was the patient's son.

Event Description

The initial reporter questioned the inr result from a coaguchek xs meter with serial number (b)(4) that was allegedly within the normal range for a patient who was allegedly not feeling well.On (b)(6) 2022 at 2:56 pm, the meter result was reported to be 2.0 inr.On (b)(6) 2022, the patient reportedly went to the hospital because he was generally not feeling well.The patient was allegedly tested at the hospital using an unknown laboratory method at 7:30 am and the result was reported to be 10.1 inr.The reporter stated that the patient was admitted and was given vitamin k, plasma, and blood transfusion.The physicians reportedly believed that the patient had a bleed.The reporter stated that the inr is now stable and the patient is scheduled for an endoscopy and colonoscopy.The reporter stated that the patient is still in the hospital.The reporter is comparing the 2.0 inr meter result on (b)(6) 2022 at 2:56 pm to the 10.1 inr laboratory result on (b)(6) 2022 at 7:30 am.The reporter stated that the patient was unable to test for a month due to errors on the meter.The reporter stated that they received an error they could not specify and an error 5.The reporter stated that they were told by their physician's nurse that they only needed to test once a month which explains the "big gap" between the last meter result and the event.The therapeutic range was reported to be 2.0-3.0 inr.Multiple attempts were made to gather additional information regarding the patient and to date, further information has not been provided.Examples of information requested include: the patient's current condition.If the patient's alleged bleed was confirmed.If the diagnostics have been performed and the results of these diagnostics.

Manufacturer Narrative

The reporter's meter was provided for investigation and was tested using retention strips and controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 5.2 inr qc 2: 5.2 inr qc 3: 5.3 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 results alleged by the customer were observed in the meter¿s patient result memory.The investigation did not identify a product problem.The cause of the event could not be determined.  medwatch fields d9 and h3 have been 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15335358
• MDR Text Key: 299057876
• Report Number: 1823260-2022-02684
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 56561322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2022
• 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: "TANSALOME"; FLUTICASONE; GABAPENTIN; METFORMIN; PREDNISONE; TIMOLOL; TRAVOPROST; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 64 KG