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); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is patient/consumer.The meter was returned for investigation.The test strips were not returned.A full display check was performed and revealed no missing or faded segments.No display issues were observed.The returned meter was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr, qc 2: 5.2 inr, qc 3: 5.0 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 patient alleged receiving error 5.A review of the meter error log revealed error 5.Error 5 occurs when the applied sample volume is insufficient or when sample detection is uncertain.Generally, this is caused by wrong handling, or by meter contamination.Product labeling for error 5 states: "error: blood application error applying blood to the test strip or blood sample size was too small.Solution: turn the meter off and remove the test strip.Re-read the instructions about applying blood (starting on page 33).Repeat the test with a new test strip and a sufficient amount of blood from a different finger.If you still get the error message, call roche customer support center at (b)(4).".A review of the meter error log revealed no result of 5.0 inr.The patient had mistaken an error 5 for a 5.0 inr result.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

We received an allegation of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.The meter result at 8:48 a.M.Was 2.4 inr.The result from an unknown laboratory method was reportedly 1.9 inr.The patient¿s therapeutic range is reportedly 2.0 ¿ 3.0 inr with a testing frequency of once a week.

• 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: 16156652
• MDR Text Key: 307331358
• Report Number: 1823260-2023-00128
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 62216023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2023
• 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: MAGNESIUM.; METOPROLOL.; WARFARIN.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG