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

Catalog Number 04625315160

Device Problems Circuit Failure (1089); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

Both meters and test strips were requested for investigation.The products have not been received at this time.If the products are 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 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.

Event Description

We received an allegation of questionable inr results for different patients tested with coaguchek xs plus meters serial numbers (b)(4) compared to an unknown laboratory method.On (b)(6) 2022 one patient had an initial meter result of 1.1 inr while the lab result was more than 3.0 inr.The reporter couldn't provide an exact value for the lab result.The time difference between the tests was within 4 hours.The test strips with the same lot number were used for both meter tests.The patient's warfarin dose was initially slightly increased for one day off the estimated meter result of 1.1 inr but then adjusted based on the lab result showing more than 3.0 inr.The patient's therapeutic range was not provided.

Manufacturer Narrative

The customer's meter (serial number (b)(6)) was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr; qc 2: 5.2 inr; qc 3: 5.2 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 customer was unable to provide exact results during the affected timeframe.Instead, the customer provided "estimations" of results and gave an example of a meter-to-lab comparison.The customer had alleged receiving unknown errors.A review of the meter error log revealed a re-occurring error e-403.Error e-403 occurs as the result of handling issues including applying samples too early, the test strip had been previously used or was wet, or the meter being contaminated by customer mishandling.Another re-occurring error observed in the meter error log is error e-405.Error e-405 occurs as the result of the test strip being moved during measurement.This is a direct result of user error.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16005083
• MDR Text Key: 308183194
• Report Number: 1823260-2022-04086
• Device Sequence Number: 1
• Product Code: GJS
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 04625315160
• Device Lot Number: 58526211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• 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