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

Catalog Number 04625374160

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

The reporter¿s meter was provided for investigation where it was tested using retention strips and controls.Testing results (qc range = 2.4 ¿ 3.6 inr): qc 1: 2.8 inr.Qc 2: 2.8 inr.Qc 3: 2.8 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.There were no errors observed during the investigation.The obtained qc values were observed in the meter memory without issues.There were no meter memory issues observed.The reported meter results of 3.8 inr and 5.2 inr were observed in the meter¿s result memory.The customer reported a missing test result from the meter memory.Product labeling states "the meter displays the result in about a minute.The meter automatically stores the result in memory so that you can easily recall results." handling errors were found in the error code report on (b)(6) 2022: error 4 - product labeling states "error: test strip unusable the test strip is unusable.Solution: turn the meter off, remove the test strip, and then re-insert it.If the error message reappears, discard the unusable test strip and use a new one." test strip error - product labeling states "error: test strip possible causes: ¿ a test strip was already inserted when the meter was turned on.¿ the meter timed out after you inserted the test strip.¿ the test strip is unusable.¿ the test strip is not a coaguchek xs pt test strip.Solution: remove the test strip.Then repeat the test with a new coaguchek xs pt test strip." 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 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 investigation did not identify a product problem.The cause of the event could not be determined.  initial reporter: occupation: patient/consumer.

Event Description

We received an allegation of a questionable inr result for one patient tested with the coaguchekxs meter with serial number (b)(4) when consecutive testing was performed and when it was compared to another meter from the doctor's clinic.The meter result at an unknown time was 6.7 inr.The reporter stated that she received this result with an unknown error message.This result was missing from the meter memory.The reporter did not believe the result and repeated the test.The meter result at 1:04 pm was 5.2 inr.The meter result at 1:12 pm was 3.8 inr.The reporter stated she went to the doctor's office where she was tested using a similar meter.The meter result from the doctor's clinic at 3:00 pm was 2.5 inr.The therapeutic range is 2.5-3.0 inr.The interval of testing is every two weeks.

• 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: 15781130
• MDR Text Key: 307791120
• Report Number: 1823260-2022-03583
• 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: 11/11/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 60124921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/11/2022
• 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: ACETAMINOPHEN; BABY ASPIRIN; CALCITRIOL; METOPROLOL; SIMVASTATIN; TORSEMIDE; VITAMIN D
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 90 KG